1. TOPIC
STUDY OF SERUM URIC ACID LEVELS IN PATIENTS OF LIVER CIRRHOSIS
AND ITS ASSOCIATION WITH SEVERITY OF DISEASE
PLAN OF THESIS
FOR DEGREE OF M.D. GENERAL MEDICINE
SUBMITTED TO
PANDIT B.D. SHARMA UNIVERSITY OF HEALTH SCIENCES, ROHTAK
BY
DR. MOHIT BOORA
(POSTGRADUATE STUDENT)
DEPARTMENT OF GENERAL MEDICINE
ADESH MEDICAL COLLEGE AND HOSPITAL,
SHAHABAD,HARYANA
2. II
ADESH MEDICAL COLLEGE, SHAHBAD, KURUKSHETRA (HARYANA)
Protocol of Thesis to be submitted towards partial fulfillment of the requirement for the Degree of MD General
Medicine.
I. Name of the candidate: Dr. Mohit Boora
2. Father's Name: Jaibir Singh
3. Address of candidate: Isharwal, Teh-Tosham, Distt-Bhiwani, Haryana
4. Name of University: Bareilly international university.
5. Year and month of passing MBBS examination: 2021 and March.
6. Date ofjoining MD/ MS course: 10/10/2024
7. Proposed subject of thesis: Study of serum uric acid levels in patients of liver cirrhosis and its
association with severity of disease.
8. Facilities for work on the subject: All facilities exist at Adesh Medical Coilege and Hospital, Shahabad.
9. Detailed scheme according to which candidate proposes to work: Plan attached.
l0. Name and address of Supervisor: Dr. Sandeep Joshi, Professor, Department of General Medicine.
11. Name and address of Co-supervisors: Dr. Tarvinderjit Khurana, Associate Professor, Department of
General Medicine.
Signature of Candidate
DR. MOHlT BOORA
3. (ANNEXURE-I)
CERTIFICATE
iii
Ve certify that all facilities for the study on the subject of the thesis entitled "Study of serum uric acid levels in
patients of liver cirrhosis and its association with severity of disease." exist in Adesh Medical College and
Hospital, Shahabad and these shall be provided to candidate Dr. Mohit Boora in pursuance of his plan of thesis.
Ve shall guide the candidate in his work and shall ensure that the data being included in the thesis are genuine
and that the work is being done by the candidate himself.
vM~
Supervisor
DR. SANDEEP JOSHI
PROFESSOR
DEPARTMENT OF GENERAL MEDICINE
Co-supervisors
DR. TARVINDERJIT KHURANA
ASSOCIATE PROFESSOR
DEPARTMENT OF GENERAL MEDICINE
4. (ANNEXURE-JI)
ETHICAL JUSTIFICATION
IV
The proposed study entitled "Study of serum uric acid levels in patients of liyer cirrhosis and its association
with severity of disease."
lnfonned written consent will be taken from all the subjects. No drugs will be administered during the study. No
invasive procedures will be done on the subjects. All the procedures including the drugs used in the study do not
carry any harmful effects on the patients. Thus, the present study is well within the ethical norms and is ethically
justified.
Signature of Candidate
Dr. Mohit Boora
~ 1
Name a~ure of
Supervisor
DR. SANDEEP JOSHI
PROFESSOR
DEPARTMENT OF GENERAL MEDICINE
Signature of HOD
DR. DALIP KUMAR GUPTA
PROFESSOR AND HEAD
DEPARTMENT OF GENERAL MEDICINE
Name and Signature of
Co-Supervisor
DR. TARVINDERJIT KHURANA
ASSOCIATE PROFESSOR
DEPARTMENT OF GENERAL MEDICINE
5. V
(ANNEXURE-11I)
Declaration by the Postgraduate Student
I hereby declare that:
1. The study will be done as per Institutional protocol and guidelines.
2. Study shall be initiated only after clearance from the institutional ethics committee.
3. Written, Infonned consent of the patients/ control (volunteers) will be obtained.
4. In case of children and tnentally handicapped both patients/ control (volunteers) written informed consent
of parents/ care givers will be obtained.
5. The probable risk involved in the study will be explained in full to the subject/parents/caregivers in their
own language.
6. I will terminate the study at any stage, If I have probable cause to believe, in the exercise of the good faith.
skill, and careful judgment required for me that continuation of the study /experiment is likely to n::sult in
injury/disability/death to the subject.
7. Disclosure:
1. Financial/Funding - None
ii. Conflict of interest - None
111. Association - None
Date --------
(SiV)latuWs~r:::
DR. SANDEEP JOSHI
PROFESSOR
Department of General Medicine
Signature of PG Student
Department of General Medicine
Dr. Mohit Boora
{Signature of SuperYisor)
DR. TARVINDERJIT KHUR.
.N..
ASSOCIATE PROFESSOR
Dcpartmc'nt of G~neral Medirinl'
6.
7. 1
INTRODUCTION
Cirrhosis is a result of a variety of liver diseases characterized by fibrosis and architectural distortion of the liver
with the formation of regenerative nodules and can have varied clinical manifestations and complications. In
2016, it accounted for 2.2% of deaths and 1.5% of disability-adjusted life years globally, making it the eleventh
(11th
) most common cause of death and the fifteenth(15th
) most common cause of morbidity. Liver damage in
CLD progresses over time and eventually results in function loss.[1]
Liver is a vital organ in the human body, responsible for various important functions including synthesis of vital
proteins, regulation of numerous metabolic processes and detoxification of various metabolites. The liver also
plays a vital role in metabolism, red blood cells regulation and glucose homeostasis. Serum enzymes used in
liver function tests include gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), and alanine and
aspartate transaminase (ALT and AST). Serum ALT is primarily found in the liver and is thought to be a specific
marker for hepatic injury, whereas serum GGT is present in maximum cells surface and highly active in the
liver, kidney and pancreas. Serum GGT is regarded as a biomarker of hepatic dysfunctions and alcohol
consumption. Furthermore, GGT mediates glutathione uptake and is thought to be connected to oxidative stress
and chronic inflammation. Elevated levels of serum ALT, and GGT are associated with various risk factors for
diabetes, metabolic syndrome and cardiovascular diseases such as hyperglycemia, obesity, dyslipidemia and
increased blood pressure. Additionally, increased levels of ALT and GGT have also been found to be associated
with NAFLD.[2]
Various etiological variables, such as alcoholic liver disease, Hepatitis B and C infection, and non-alcoholic
fatty liver disease (NAFLD/NASH), can all contribute to the development of chronic liver disease., autoimmune
hepatitis and hepatocellular carcinoma. In consequence to chronic hepatic damage, cirrhosis is represented as
histopathological development of regenerating nodules encircled with bands of fibrosis which causes portal
hypertension as well as end-stage liver disease. Continuance of the normal tissue repair reaction leads to an
aberrant prolongation of fibrogenesis, which causes hepatic fibrosis. Cirrhosis is defined clinically as
compensated or decompensated. Ascites, variceal haemorrhage, encephalopathy, or jaundice are symptoms of
decompensated cirrhosis, which are complications of the major effects of cirrhosis: portal hypertension and liver
insufficiency.[3]
Uric acid (UA), is byproduct of purine metabolism in humans and higher primates, and it is eliminated through
urine. Kidney stones and gouty arthritis are known to be caused by hyperuricemia. In recent times, there has
8. 2
been an association between hyperuricemia and the onset of hypertension, kidney disease, metabolic syndrome,
and cardiovascular disease.[4]
High level of uric acid (UA) in chronic liver disease is independently linked to a poor prognosis and a more
severe form of the disease. In addition to being a byproduct of purine metabolism and cell death, UA has also
been linked to inflammation and tissue damage, according to recent studies.[1]
. High amounts of UA have been
observed in CLD with various aetiologies. High levels of UA have been identified as distinct etiological risk
factors for individuals suffering from non-alcoholic fatty liver disease (NAFLD). In different studies, Uric acid
levels have been found to correlate directly with the level of tissue damage.[1]
Non-alcoholic fatty liver disease (NAFLD), has emerged as a leading cause of chronic liver disease worldwide
with a rapidly growing prevalence in the general population, ranging between 20% and 30%. During the last
few years, among the several parameters evaluated as possible predictors of NAFLD, serum uric acid (SUA) is
one of the parameters that has emerged. In fact, increasing evidence has shown that SUA levels are associated
with the metabolic insulin resistance syndrome, higher body fat content and more severe liver damage.[5]
Hyperuricemia has also been linked to hypertension, metabolic syndrome, cardiovascular disease, and renal
disease. Uric acid is created in situations that cause cellular death and nuclear material deterioration. Uric acid
in tissues stimulates inflammation and causes tissue damage. Because high uric acid levels are a recognised side
effect of alcohol metabolism, hyperuricemia may be detected in alcoholic liver disease.[3]
Elevated serum uric
acid level might be a risk factor for the incidence of liver cirrhosis. Hyperuricemia may act as a surrogate
marker for assessing the prognosis of Liver cirrhosis.[6]
The Child-Pugh score is a system used to assess the prognosis of chronic liver disease, primarily cirrhosis. It
uses five clinical measures of liver disease:- total bilirubin, serum albumin, prothrombin time or INR, ascites,
and hepatic encephalopathy. Each measure is scored from 1 to 3, with 3 indicating the most severe
derangement. The total score ranges from 5 to 15 and is classified into three classes:
Class A (5-6)- well compensated
Class B (7-9) – significant functional compromise
Class C (10-15) - Decompensated.
The higher the score and class, the worse the prognosis and the higher the risk of mortality and complications.
The Child-Pugh score is used to determine the severity of liver disease. It is also used as a stratification tool in
9. 3
clinical trials and as a comparison tool in epidemiological studies. It is widely used in clinical practice because
it is simple, inexpensive, and reliable.
Child Pugh Score is calculated based on following parameters:
SCORE
PARAMETER SCORE 1 SCORE 2 SCORE 3
ALBUMIN (g/dl) >3.5 2.8-3.5 <2.8
BILIRUBIN (mg/dl) <2 2-3 >3
INR <1.7 1.7-2.3 >2.3
ENCEPHALOPATHY None Grade 1-2 Grade 3-4
ASCITES Absent Slight Moderate
[7]
Liver Cirrhosis is one of the major causes of morbidity and mortality in our nation. Since the damage to the
liver is irreversible, we must look for multiple severity markers or predictors for the patient's prognosis.
Increased insulin resistance, metabolic syndrome, and oxidative stress are all risk factors for the development of
liver disease, and elevated serum uric acid (UA) levels may even exacerbate these conditions.[4,8]
Our goal in
this study is to study the serum Uric acid level in patients of Liver Cirrhosis and to analyse any relationship
between the level of serum uric acid and the severity of Liver Cirrhosis as indicated by a Child-Pugh score.
10. 4
REVIEW OF LITERATURE
Chander R et al conducted a cross sectional study Among 50 patients, majority of them were male constituting
82% (n = 41). Females were 18 % (n = 9). Male: Female was 4.5:1. Among 50 cirrhotic patients, most of the
patients belonged to CTP class C (44%) followed by CTP class B (40%) and then by CTP class A (16%).The
mean serum uric acid of study population was 6.45±2.25 mg/dl. CTP score was used to assess the severity and
prognosis of cirrhosis of liver in this study. In CTP class A, the mean serum uric acid level was 4.42±1.18 mg/dl.
In class B and class C, the mean serum uric acid levels were higher: 5.49±1.49 mg/dl and 8.07±2.04 mg/dl
respectively. The difference was statistically significant (p value=0.001). Pearson’s correlation coefficient was
used to assess the relation between serum uric acid level and CTP score and there was a positive correlation
between the two variables with r value of 0.7 and p value of 0.001. This study established a statistically significant
positive correlation between serum uric acid levels and CTP score. [9]
Molla NH et al conducted a cross sectional study A total of 410 participants were included in this study; about
74.1% (n=304) were males and 25.9% (n=106) were females. The mean age (±SD) of the study subjects was
36±11 years which range from 20 to 65 years. The mean BMI of the study participants was 24.4±3.5 kg/m2 with
no significant difference between males and females. The mean level of SBP, SUA, ALT, AST and GGT were
significantly higher in males than in the female participants (at least pt p<0.05 for all cases). However, the mean
level of serum TG and HDL were significantly higher in females than in the male (p<0.01 for both cases) subjects.
There were no significant differences in the mean level of DBP, FBG, TC, and LDL-C, in the male–female groups.
The overall prevalence of hyperuricemia was 30.1% with 32.2% in male and 18.6% in female subjects. [10]
Noklang S et al conducted a cross sectional observational study Fifty patients diagnosed with CLD, aged between
18 and 65 years, of either gender, were enrolled in the study. Serum UA levels were measured, and liver function
and coagulation parameters were assessed. A statistical analysis was performed to evaluate the association
between serum UA levels, liver function test, and coagulation parameters. In study, the mean serum UA level
was 6.52 mg/dl and was raised in patients with CLD in correlation to its severity. Alcoholic liver disease (ALD)
was the most common etiology for CLD (80%) followed by hepatitis B (Hep B) virus infection (12%) and
hepatitis C (Hep C) virus infection (6%). Serum UA levels increased as the Child–Turcotte–Pugh (CTP) score
increased. The mean UA level in CTP class C was 8.29 mg/dl. Various parameters such as serum aspartate
aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, total bilirubin, international
normalized ratio (INR), calcium, and albumin were significantly associated with serum UA levels in CLD
patients. The correlation between rising blood UA levels and the Child–Pugh score shows that UA estimate may
be a valid and affordable indicator for assessing the extent of liver cirrhosis in CLD. [11]
11. 5
Prakash BC et al conducted a cross sectional study on 100 patients with stigmata of liver cell failure on clinical
examination and substantiated by imaging. Serum Uric acid and other biochemical parameters were determined.
Child Turcotte Pugh Score, Model for End Stage Liver Disease (MELD) score, United Kingdom Model for End
Stage Liver Disease (UKELD) score was calculated and the correlation obtained. The study showed significant,
positive correlation between uric acid level and CTP, MELD and UKELD score. The study also showed the
positive correlation of serum uric acid with various biochemical parameters such as total bilirubin, Prothrombin
time/ International Normalized Ratio (PT/INR) and serum creatinine and negative correlation with serum
albumin, with a significant p value. The mean serum uric acid was found to be 4.79(4.79± 2.0). Hence serum uric
acid can be used as an alternative prognostic parameter in predicting the severity and prognosis of cirrhosis of
liver. [12]
Paul R et al conducted a cross sectional observational study. They had a total of 52 patients in their study with
31 % female. 19 of the cases had liver disease secondary to alcoholism followed by 15 cases of non-alcoholic
fatty liver disease. 69.2% of the patients were in CTP class B or C. Serum uric acid levels are significantly
higher in chronic viral hepatitis cases. Uric acid levels showed significant correlation with severe disease and
mortality. [13]
Feng Y et al conducted a cross sectional study 3919 individuals participated in this study. There was a positive
association between SUA (µmol/L) and CAP (β=0.14, 95% CI: 0.12-0.17, P<0.01). After stratification by sex, a
significant relationship between SUA and CAP existed in both males (β=0.12, 95% CI: 0.09-0.16, P<0.01) and
females (β=0.17, 95% CI: 0.14-0.20, P<0.01) after multiple imputation. The inflection points of the threshold
effect of SUA on CAP were 487.7 µmol/L in males and 386.6 µmol/L in females. There was a positive association
between SUA (mg/dL) and NAFLD (OR=1.30, 95% CI: 1.23-1.37, P<0.01). After stratification by race, positive
relationships were also observed. Meanwhile, a positive relationship existed between hyperuricemia and NAFLD
(OR=1.94, 95% CI: 1.64-2.30, P<0.01). The positive relationship was more significant in females than in males
(P for interaction<0.01). There was a positive association between SUA and CAP, as well as between SUA and
NAFLD. [14]
12. 6
RESEARCH QUESTION
1. To study whether there is an association between serum uric acid levels and severity of liver cirrhosis?
13. 7
AIM & OBJECTIVES
AIM :- Study of serum uric acid levels in patients of liver cirrhosis and its association with severity of
disease
OBJECTIVES
To measure Serum uric acid levels in patients of liver cirrhosis.
To explore the association between serum uric acid levels and severity of liver cirrhosis.
14. 8
MATERIALS & METHODS
STUDY DESIGN- Cross-sectional observational study.
STUDY SETTING- Hospital based study to be conducted in the department of medicine of Adesh Medical
College and Hospital, Shahabad, Haryana.
STUDY POPULATION- Patients diagnosed with liver cirrhosis presenting in outpatient and indoor facilities
of department of medicine.
SAMPLE SIZE CALCULATION - The sample size is calculated based on previous studies where 63.6%
of the patients of cirrhosis had elevated elevated uric acid level.[15]
The adequate required sample size was estimated using the following formula:
𝑛 =
𝑍2
𝑃(1 − 𝑃)
𝑑2
𝑤ℎ𝑒𝑟𝑒 𝑛 = 𝑠𝑎𝑚𝑝𝑙𝑒 𝑠𝑖𝑧𝑒
𝑍 = 𝑍 𝑠𝑡𝑎𝑡𝑖𝑠𝑡𝑖𝑐 𝑓𝑜𝑟 𝑙𝑒𝑣𝑒𝑙 𝑜𝑓 𝑐𝑜𝑛𝑓𝑖𝑑𝑒𝑛𝑐𝑒
𝑃 = 𝑃𝑒𝑟𝑣𝑎𝑙𝑒𝑛𝑐𝑒 𝑜𝑓 ℎ𝑦𝑝𝑒𝑟𝑢𝑟𝑖𝑐𝑒𝑚𝑖𝑎 𝑖𝑛 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠 𝑜𝑓 𝑙𝑖𝑣𝑒𝑟 𝑐𝑖𝑟𝑟ℎ𝑜𝑠𝑖𝑠
𝑑 = 𝑅𝑒𝑙𝑎𝑡𝑖𝑣𝑒 𝑝𝑟𝑒𝑐𝑖𝑠𝑖𝑜𝑛
We calculated the sample size by taking the prevalence level of 63.6%.
The sample size was calculated at 95 level of confidence, 63.6% prevalence, 15% relative precision.
n= 98.
Non-response rate: n* = 10 %
After adjusting the non-response rate of 10%, the final minimum sample size comes to be 108.
We are taking the sample size of 110 in this study.
DURATION OF STUDY- From approval of the thesis plan to June, 2025 (approximately).
15. 9
INCLUSION CRITERIA:
1. Patients attending outpatient and inpatient facilities in medicine department with diagnosis of Liver
Cirrhosis.
2. Patients who will be willing to participate and give written informed consent.
3. Men, women and other genders.
4. Patient age 18 years and above.
EXCLUSION CRITERIA:
1. Individuals not willing to participate in study.
2. Pregnant women.
3. Patient with h/o Gout.
4. Patient with malignancy.
5. Known case of chronic kidney disease.
6. Patients of hepato-renal syndrome.
7. Patient on drugs which cause alterations in uric acid levels such as Allopurinol, Febuxostat, Thiazides,
Furosemide etc.
16. 10
METHODOLOGY:
This hospital based cross sectional study will be conducted in the department of Medicine at Adesh medical
college and hospital, Shahabad, Haryana. The patients attending the outpatient and inpatient facilities of
department of medicine department, with history of hepatic cirrhosis, who meet the inclusion criteria of this study
and those who are willing to participate in the study and give written informed consent will be evaluated further.
Those patients who will not be able to give written informed consent, consent will be obtained from patient’s
relatives for participation in the study.
All subjects who consent for the study will be examined.
A detailed History, History of present Illness symptoms of complications such as bleeding (hematemesis, melena),
abdominal distension, encephalopathy, past history, personal history including risk factors for chronic liver
disease such as viral hepatitis (travel, transfusion, sexual contacts, occupation), chronic alcoholism, blood
transfusion and surgeries will be taken.
Patients will be subjected to thorough Examination including General Physical examination and systemic
examination with special emphasis on features of chronic liver disease e.g., jaundice, ascites, pitting edema,
palmar erythema, encephalopathy, asterixis, spider naevi, gynecomastia, altered sexual features, gonadal
examination, hepatomegaly, splenomegaly. Abdominal ultrasonography will be done for all subjects.
Diagnosis of Hepatic cirrhosis will be based on clinical evaluation, laboratory tests and radiological study.
Clinical features: Signs and symptoms of hepatic insufficiency and other complication of cirrhosis such as -
Fatigue, Easily bleeding or bruising, Loss of appetite, Nausea, Swelling in the legs, feet or ankles i.e. edema,
Weight loss, Itchy skin, Yellow discoloration in the skin and eyes, Ascites, Spiderlike blood vessels on the skin.
Redness in the palms of the hands, Clubbing of the fingers. Confusion, drowsiness or slurred speech
In women - absence of or loss of periods not related to menopause.
In men, loss of sex drive, testicular shrinkage or gynecomastia.
Patients will be subjected to the routine work up for hepatic cirrhosis including:
Laboratory tests: CBC, Liver function tests, Coagulation profile, Renal function test, Serum uric acid, viral
serology, ascitic fluid analysis.
Radiology: USG Abdomen.
Patients will be categorised based on Child Pugh Score criteria.
17. 11
For Serum uric acid levels calculation
It will be measured once at the time of admission (in case of indoor patients) or on presentation in OPD (in case
of outdoor patients).
Type of specimen: Unhaemolysed serum
Method: This reagent is based on trinder reaction. The series of reactions involved in the assay system is as
follows:
Uric acid is oxidised to allantoin by uricase with production of H2O2.
The peroxide reacts with 4-aminoantipyrine(4-AAP) and TOOS in the presence of peroxidase to yield a
quinoeimine dye. The absorbance of this dye at 546nm is proportional to uric acid concentration in the sample.
Calibration and quality control
Calibrated with serum based XL Multi calibrator. For quality control, ERBA NORM and ERBA PATH are used.
Normal Reference Range:
Adults Male: 2.5-7.0 mg/dl
Adults Female: 1.5-6.0 mg/dl. [16]
Patients will be further evaluated by using Child-Pugh-Turcotte (CTP) score. This scale is valid, reliable and
freely available.
Data collection will be started after the approval of the thesis plan. Data collected will be statistically analyzed
subsequently.
18. 12
STATISTICAL ANALYSIS
The data will be captured on the physical proforma and a master chart will be prepared in the Microsoft Excel.
The statistical analysis will be carried out using SPSS 27.0 (IBM, Trialware, USA). Mean will be used as measures
of central tendency for quantitative variables and standard deviation will be used as measure of variability in data.
Qualitative variable will be described in frequencies and fraction of total. To compare two quantitative variables,
unpaired t-test will be used. For qualitative variables, Chi-square test will be used for comparison between the
two groups. All tests will be tested at 5% level of significance. All statistical tests will be performed by taking
significance level of α = 0.05. Appropriate tables and graphs will be used to represent the data.
19. 13
FLOW DIAGRAM OF STUDY
Patients diagnosed with liver cirrhosis presenting in outpatient and
indoor facilities of department of medicine.
Excluded :
Individuals not willing to participate in
study.
Pregnant women.
Patient with h/o Gout.
Patient with malignancy.
Known case of chronic kidney disease.
Patients of hepato-renal syndrome.
Patient on drugs which cause alterations in
uric acid levels such as Allopurinol,
Febuxostat, Thiazides, Furosemide etc.
Included :
1. Patients who will be willing to participate
and give written informed consent.
2. Men, women and other genders.
3. Patient age 18 years and above.
Measurements of serum uric
acid and CTP score.
Analysis of the data using
Standard Statistical Analysis
20. 14
REFRENCES
1. Noklang S, Noklang I, Chirumamilla SSK, Kannauje PK. Serum uric acid level in chronic liver disease and its correlation with
Child–Pugh score in a tertiary care hospital from South India. Journal of Family Medicine and Primary Care. 2023
Nov;12(11):2696-701.
2. Molla NH, Kathak RR, Sumon AH, Barman Z, Mou AD, Hasan A, et al. Assessment of the relationship between serum uric
acid levels and liver enzymes activity in Bangladeshi adults. Scientific Reports. 2021 Oct 11;11(1).
3. M DM. Study of serum uric acid level in chronic liver disease and its correlation with Child-Turcotte-pugh score and platelet
indices. Journal of Medical Science And clinical Research. 2022 Feb 28;10(02).
4. Noklang S, Noklang I, Chirumamilla SSK, Kannauje PK. Serum uric acid level in chronic liver disease and its correlation with
Child–Pugh score in a tertiary care hospital from South India. Journal of Family Medicine and Primary Care. 2023
Nov;12(11):2696-701.
5. Lombardi R, Pisano G, Fargion S. Role of Serum Uric Acid and Ferritin in the Development and Progression of NAFLD. Int
J Mol Sci. 2016 Apr 12;17(4):548.
6. Gupta PK, Agarwal H, Singhal S, Manocha K. Study of association between serum uric acid levels and chronic liver disease.
Eur J Mol Clin Med [Internet]. 2021 [cited 2024 Jan 23];8(4):1169–74.
7. Tsoris A, Marlar CA. Use of the Child Pugh Score in Liver Disease. In: StatPearls [Internet]. Treasure Island (FL): StatPearls
Publishing; 2024.
8. Afzali A, Weiss NS, Boyko EJ, Ioannou GN. Association between serum uric acid level and chronic liver disease in the United
States. Hepatology. 2010 Aug;52(2):578-89.
9. Chander R, Kumar Y, Singh K, Aloona SP, Singh R. Serum uric acid levels in chronic liver disease and its relation to Child
Turcotte Pugh (CTP) score1. Int J Life Sci Biotechnol Pharma Res. 2023 Jul-Sep;12(3):310-6.
10. Molla NH, Kathak RR, Sumon AH, Barman Z, Mou AD, Hasan A, et al. Assessment of the relationship between serum uric
acid levels and liver enzymes activity in Bangladeshi adults. Scientific Reports. 2021 Oct 11;11(1):20114.
11. Noklang S, Noklang I, Chirumamilla SSK, Kannauje PK. Serum uric acid level in chronic liver disease and its correlation with
Child-Pugh score in a tertiary care hospital from South India. J Family Med Prim Care. 2023 Nov;12(11):2696-2701.
12. Prakash BC, Rai SK. Study of serum uric acid in liver cirrhosis and its correlation with Child Turcotte Pugh, MELD and
UKELD score. Int J Res Med Sci [Internet]. 2020 Jan. 27 [cited 2024 Jan. 31];8(2):450-4.
13. Paul R, Chakravarti HN, Mandal SK, Chatterjee S, Choudhury PS. Study of serum uric acid in chronic liver disease and its
relation with other parameters. Int Res J Pharm. 2013;4(7):162-5
14. Feng Y, Zheng S, Liu L, Yang Y. Association of serum uric acid with hepatic steatosis detected by controlled attenuation
parameter in the United States population. Lipids Health Dis. 2023 Jun 20;22(1):76.
15. Sebasan RV, Baliga KV. Study of prevalence of hyperuricemia in chronic liver disease patients and correlate with severity of
chronic liver disease. Int J Sci Stud. 2021 Aug;9(5):149-523.
16. Jin M, Yang F, Yang I, Yin Y, Luo JJ, Wang H, Yang XF. Uric acid, hyperuricemia and vascular diseases. Front Biosci. 2012
Jan 1; 17: 656–669.
21. 15
PATIENT INFORMATION SHEET
Title: Study of serum uric acid levels in patients of liver cirrhosis and its association with severity of disease.
Principal Investigator: Dr. MOHIT BOORA
Name of Participant:
Site: Department of Medicine, Adesh Medical College and Hospital, Shahabad.
You are invited to take part in this research. The information in this document is meant to help you decide whether
or not to take part. Please feel free to ask if you have any queries or concerns.
What is the purpose of research?
Liver cirrhosis is one of the major causes of morbidity and mortality in our nation. Since the damage to the liver
is irreversible, we are looking for easily accessible and reliable severity marker or predictor for the patient's
prognosis.
We have obtained permission from the Institutional Ethics committee
The study design:
Study will be done at OPD and IPD facilities of Department of medicine, Adesh medical college, Shahabad.
Among the patients who fulfills inclusion criteria, giving their consent will be taken up for the study. Association
of serum uric acid levels in will be assessed in patients with liver cirrhosis.
Study Procedures:
Study will include a population of patients attending outpatient and inpatient facilities of Department of General
Medicine, and diagnosed with liver cirrhosis. They will be chosen for study after taking an informed consent.
Later, standard assessment tools (LFT, S. uric acid, CTP score) will be used to assess the Association of serum
uric acid levels in patients with liver cirrhosis. Various data obtained will be analyzed statistically to get the
results.
22. 16
Confidentiality of the information obtained from:
You have the right to confidentiality regarding the privacy of your medical information (personal details, results
of physical examinations, investigations, and your medical history). By signing this document, you will be
allowing the research team investigators, other study personnel, Institutional Ethics Committee and any person or
agency required by law like the Drug Controller General of India to view your data, if required.
The information from this study, if published in scientific journals or presented at scientific meetings, will not
reveal your identity.
How will your decision to not participate in the study affect you?
Your decision not to participate in this research study will not affect your medical care or your relationship with
the investigator or the institution. You will be taken care of and you will not lose any benefits to which you are
entitled.
Can you decide to stop participating in the study once you start?
The participation in this research is purely voluntary and you have the right to withdraw from this study at any
time during the course of the study without giving any reasons. However, it is advisable that you talk to the
research team prior to discontinuing from the study.
Signature of Investigator Signature of Participant
Date: Date:
Signature of the witness Signature of the relative/informant
Date: Date:
23. 17
रोगी सूचना पत्र
शीर्षक: लिवर लिरोलिि क
े रोलियोों में िीरम यूररक एलिड क
े स्तर और रोि की िोंभीरता क
े िाथ इिक
े िोंबोंध का अध्ययन।
प्रधान अन्वेर्क: डॉ मोलित बूरा
प्रलतभािी का नाम:
िाइट: और्लध लवभाि, आदेश मेलडकि कॉिेज और अस्पताि, शािाबाद।
आपको इि शोध में भाि िेने क
े लिए आमोंलित लकया जाता िै। इि दस्तावेज़ में दी िई जानकारी का उद्देश्य यि तय करने में
आपकी ििायता करना िै लक भाि िेना िै या निीों क
ृ पया बेलििक पूछें लक क्या आपक
े कोई प्रश्न या ल ोंताएँ िैं |
अनुिोंधान का उद्देश्य क्या िै?
लिवर लिरोलिि िमारे देश में रुग्णता और मृत्यु दर क
े प्रमुख कारणोों में िे एक िै। ूँलक िीवर की क्षलत अपररवतषनीय िै, िम
रोिी क
े पूवाषनुमान क
े लिए आिानी िे िुिभ और लवश्विनीय िोंभीरता माक
ष र या भलवष्यवक्ता की तिाश कर रिे िैं।
िमने िोंस्थाित आ ार िलमलत िे अनुमलत प्राप्त कर िी िै
अध्ययन लडजाइन:
आदेश मेलडकि कॉिेज, शािाबाद क
े मेलडलिन लवभाि की ओपीडी और आईपीडी िुलवधाओों पर अध्ययन लकया जाएिा।
जो मरीज़ िमावेशन मानदोंडोों को पूरा करते िैं, उनकी ििमलत देकर अध्ययन में भाि लिया जाएिा। लिवर लिरोलिि क
े
रोलियोों में िीरम यूररक एलिड क
े स्तर क
े िोंबोंध का मूल्ाोंकन लकया जाएिा।
अध्ययन प्रलियाएों :
अध्ययन में िामान्य ल लकत्सा लवभाि की बाह्य रोिी और आोंतररक रोिी िुलवधाओों में भाि िेने वािे और लिवर लिरोलिि िे
लनदान लकए िए रोलियोों की आबादी शालमि िोिी। िूल त ििमलत िेने क
े बाद उन्हें अध्ययन क
े लिए ुना जाएिा। बाद में,
िीवर लिरोलिि वािे रोलियोों में िीरम यूररक एलिड स्तर क
े एिोलिएशन का आकिन करने क
े लिए मानक मूल्ाोंकन
उपकरण (एिएफटी, एि यूररक एलिड, िीटीपी स्कोर) का उपयोि लकया जाएिा। पररणाम प्राप्त करने क
े लिए प्राप्त लवलभन्न
आोंकडोों का िाोंख्यिकीय लवश्लेर्ण लकया जाएिा।
प्राप्त जानकारी की िोपनीयता:
24. 18
आपक
े पाि अपनी ल लकत्सा जानकारी (व्यख्यक्तित लववरण, शारीररक जाों क
े पररणाम, जाों , और आपक
े ल लकत्सा इलतिाि)
की िोपनीयता क
े िोंबोंध में िोपनीयता का अलधकार िै। इि दस्तावेज़ पर िस्ताक्षर करक
े , आप अनुिोंधान दि जाों कताषओों,
अन्य अध्ययन कलमषयोों को अनुमलत देंिे। िोंस्थाित आ ार िलमलत और लकिी भी व्यख्यक्त या एजेंिी को आपक
े डेटा को देखने
क
े लिए भारत क
े डर ि क
ों टर ोिर जनरि जैिे कानून की आवश्यकता िोती िै, यलद आवश्यक िो |
इि अध्ययन की जानकारी, यलद वैज्ञालनक पलिकाओों में प्रकालशत हुई िै या वैज्ञालनक बैठकोों में प्रस्तुत की िई िै, तो इििे
आपकी पि ान उजािर निीों िोिी |
अध्ययन में भाि न िेने का आपका लनणषय आपको क
ै िे प्रभालवत करेिा?
इि शोध अध्ययन में भाि न िेने का आपका लनणषय आपकी ल लकत्सा देखभाि या अन्वेर्क या िोंस्था क
े िाथ आपक
े िोंबोंधोों
को प्रभालवत निीों करेिा। आपकी देखभाि की जाएिी और आप कोई भी िाभ निीों खोएों िे लजिक
े आप िकदार िैं |
क्या आप एक बार शुरू करने क
े बाद अध्ययन में भाि िेना बोंद करने का लनणषय िे िकते िैं?
इि शोध में भािीदारी लवशुद्ध रूप िे स्वैख्यिक िै और आपको अध्ययन क
े दौरान लकिी भी िमय लबना कोई कारण बताए
इि अध्ययन िे िटने का अलधकार िै। िािाोंलक, यि ििाि दी जाती िै लक आप अध्ययन बोंद करने िे पििे शोध दि िे बात
करें |
अन्वेर्क क
े िस्ताक्षर प्रलतभािी का िस्ताक्षर
तारीख: तारीख:
िाक्षी क
े िस्ताक्ष ररश्तेदार/मुखलबर क
े िस्ताक्षर
तारीख: तारीख:
25. 19
INFORMED CONSENT FORM [In English]
Title of Project: Study of serum uric acid levels in patients of liver cirrhosis and its association with severity of
disease.
Patient identification number of Thesis: ________________
Name of Investigator: DR. MOHIT BOORA Mobile No: ____________________
The contents of the information sheet dated …………………. (Version) ………… that was provided have been
read carefully by me/explained in detail to me, in a language that I comprehend, and I have fully understood the
contents. I confirm that I have had the opportunity to ask questions. The nature and purpose of the study and its
potential risk/ benefits and expected duration of the study and other relevant details of the study have been
explained to me in detail. I understand that my participation is voluntary and that I am free to withdraw at any
time, without giving any reason, without my medical care or legal right being affected.
I understand that the information collected about me from my participation in this research and sections of any of
my medical notes may be looked at by responsible individuals from Adesh Medical College and Hospital or from
regulatory authorities where it is relevant to my taking part in the research. I give the permission for these
individuals to have access to my records, to present in meetings and conferences, and publications as desired. I
agree to take part in the above study.
…………………………………… Date:
(Signature/Left thumb Impression) Place:
Name of the Participant: __________________________________
Son/Daughter/Wife: ____________________________________
Complete postal address: __________________________________
This is to certify that the above consent has been obtained in my presence.
………………………………………
Signature of Investigator Date: Place:
Witness-1 Witness-2
(Name and signature) (Name and signature)
Name of Supervisor with designation:…………….. Name of co-supervisor with designation:..………….
26. 20
सूचचत सहमचत फॉमम
पररयोजना का शीर्षक: लिवर लिरोलिि क
े रोलियोों में िीरम यूररक एलिड क
े स्तर और रोि की िोंभीरता क
े िाथ इिक
े िोंबोंध
का अध्ययन।
थीलिि की रोिी पि ान िोंिा:
अन्वेर्क का नाम: डॉ मोलित बूरा मोबाइि न:_____________________
िू ना पि लदनाोंक……………. (िोंस्करण)…………….. की िामग्री जो प्रदान की िई थी, उिे मेरे द्वारा िावधानीपूवषक पढा
िया िै/मुिे लवस्तार िे िमिाया िया िै, लजि भार्ा में मैं िमिता हों, और मैं पूरी तरि िे िमि िया हों िामग्री। मैं पुलि करता
हों लक मुिे प्रश्न पूछने का अविर लमिा िै। अध्ययन की प्रक
ृ लत और उद्देश्य और इिक
े िोंभालवत जोख्यखम/िाभ और अध्ययन
की अपेलक्षत अवलध और अध्ययन क
े अन्य प्रािोंलिक लववरणोों क
े बारे में मुिे लवस्तार िे बताया िया िै। मैं िमिता हों लक मेरी
भािीदारी स्वैख्यिक िै और मैं लकिी भी िमय, लबना कोई कारण बताए, अपनी ल लकत्सा देखभाि या कानूनी अलधकार को
प्रभालवत लकए लबना वापि िेने क
े लिए स्वतोंि हों।
मैं िमिता हों लक इि शोध में मेरी भािीदारी िे मेरे बारे में एकि की िई जानकारी और मेरे लकिी भी मेलडकि नोट क
े
अनुभािोों को आदेश मेलडकि कॉिेज और अस्पताि या लनयामक प्रालधकरणोों क
े लजम्मेदार व्यख्यक्तयोों द्वारा देखा जा िकता
िै, जिाों यि शोध में मेरे भाि िेने क
े लिए प्रािोंलिक िो। मैं इन व्यख्यक्तयोों को अनुमलत देता हों लक वे मेरे ररकॉडष तक पहुों िक
ें ,
बैठकोों और िम्मेिनोों, और प्रकाशनोों में वाोंलछत क
े रूप में प्रस्तुत कर िक
ें । मैं उपरोक्त अध्ययन में भाि िेने क
े लिए ििमत
हों।
(िस्ताक्षर/बाएों अोंिूठे का लनशान) तारीख: स्थान:
प्रलतभािी का नाम: _____________________________ बेटा/बेटी/पत्नी: _________________________________
पूरा डाक पता: _________________________________
यि प्रमालणत लकया जाता िै लक उपरोक्त ििमलत मेरी उपख्यस्थलत में प्राप्त की िई िै।
अन्वेर्क क
े िस्ताक्षर तारीख: स्थान:
िाक्षी-1(नाम और िस्ताक्षर) िाक्षी-2(नाम और िस्ताक्षर)
पद क
े िाथ पयषवेक्षक का नाम: ............................. पदनाम क
े िाथ िि पयषवेक्षक का नाम: ……………………………..
27. 21
PROFORMA
STUDY OF SERUM URIC ACID LEVELS IN PATIENTS OF LIVER CIRRHOSIS AND ITS
ASSOCIATION WITH SEVERITY OF DISEASE
NAME: AGE AND SEX: DATE:
MARITAL STATUS: EDUCATION:
RELIGION: UHID:
ADDRESS:
PHONE NUMBER:
Height Weight BMI Waist(cm)
Chief Complaints:
History of present illness:
Past History:
Drug History:
Personal History:
Family History:
GENERAL PHYSICAL EXAMINATION:
