Evidence based outcomes from IDPN therapy Referral Criteria for IDPN Achieving optimum outcomes from IDPN therapy

1. Advanced Overview of IDPN
Vishal Bagchi MBA,RD, LD
Director of Medical and Scientific Affairs
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2. Disclosure
• Vishal Bagchi is employed by Patient Care
America
• Slides are scientific and based on information
and research evidence available during the time
of the lecture
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3. Objective
Overview of safety and efficacy of IDPN. Research
based evidence to prove other benefits besides
improvement in albumin. Review recent literature
for parenteral nutrition.
• Discuss Evidence based outcomes from IDPN
therapy
• Identify patients based on referral criteria
• Identify methods to overcome barriers in
achieving optimum outcomes from IDPN therapy
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4. History of IDPN
• 1970-Furst Et. Al - EAA increased protein synthesis in plasma and skeleton
muscle
• 1971 Noree et al and 1972 Bergstrom et al showed improved nitrogen balance
• 1975-Long-term effects of essential amino acids supplementation in patients
on regular dialysis treatment.
– Heidland A, Kult J. Clin Nephrol. 1975 Jun;3(6):234-9.
– 18 patients, 1gm/kg body weight protein
– 60 weeks) of essential amino acids (EAA) and histidine at the end of each
hemodialysis(90 min)
– Improved the serum concentrations of the investigated proteins, whereas the
serum concentration of inorganic phosphorus decreased slightly
– Interruption of the EAA therapy for 16 weeks in the 13 patients studied resulted in
a decrease of transferrin and various factors of the complement system.
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5. History Continued
• 2000- NMC $486 million to settlement for IDPN
– NMC organized an IDPN Task Force in 1989 to prepare paperwork to bill old,
previously unbilled, or denied IDPN claims, even though many of the patients
lacked the clinical indications mandated by Medicare
– The government charges that when NMC discovered that medical
documentation for many patients was lacking, it instructed the Task Force to
use "clinical creativity" to prepare the required documentation
– NMC directed its IDPN coordinators to use a new sample calculation tool for
existing patients.
– It said NMC would start with the final number desired and then fill in the time
estimates needed to reach that number.
– Fresenius, which merged with NMC in 1996, also agreed to the most
comprehensive corporate integrity agreement (CIA) ever imposed on a
company doing business with the federal health care programs.
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6. Protein Energy Wasting
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7. Outcomes on IDPN from Evidence-based
Medicine
• Increase nPCR. 3
• Increase Albumin/Prealbumin: 2,4,5
• Prevent PEW/Catabolic Effect Of
Dialysis 1
• Decrease Malnutrition/Increase
Appetite 9
• Decrease Mortality 7,8
• Reduced treatment cost 8
7
• Improve Inflammation Marker, Decrease
Crp Levels 6,10
– Anecdotally lowing of other Acute Phase
Proteins such as Ferritin
• Improved Recovery From Major Surgery,
I.E. Limb Amputations Or From Other
Medical Infectious Conditions6
• Decrease Infection & Hospitalization
Rate 8
Heidland & Kult 1975

8. Anecdotal and Empirical Discussion
• Improve Fluid Balance* [Mobility of Extracellular fluid as amino acid infusion changes
osmotic pressure gradients and albumin maintains osmotic pressure]
• Short Term: Keep Patient Stable For Transplant – Surgeons hesitant to operate with low
albumin*
– Faster recovery post transplant
• Wound Healing promoted by reduced Inflammation and improved availability of
plasma proteins*
– Mainly Albumin, Globulins and Fibrinogen
• Improve skeletal muscle mass
– Body Composition & Overall Well Being leading to Higher Quality Of Life
• Increase Hemoglobin, Decreased EPO resistance and reduced EPO usage
– Evidenced by reduction of inflammation marker Ferritin and able to utilize Iron more efficiently
• May reduce cramping and hypotension1,2,3
8*Further research is needed
1. Wilkinson R, Barber SG, Robson V. Cramps, thirst and hypertension in hemodialysis patients -- The influence of dialyzate sodium concentration. Clin Nephrol 7:101-105, 1977
2. Brass EP, Adler S, Sietsema K, Amato A, Esler A, Hiatt WR. Peripheral arterial disease is not associated with an increased prevalence of intradialytic cramps in patients on maintenance hemodialysis. Am
J Nephrol 22:491-496, 2002
3. Riely JD, Antony SJ. Leg cramps: Differential diagnosis and management. Am Fam Physician 52:1794-1798, 1995

9. Body Fluid Osmolarity
MS Myers, Netter’s Essential Physiology 2016

10. Amino Acid Infusion
• Amino Acid molecules attract fluid in the 3rd space to
enter the vasculature
• 20% Prosol - 1835 mOsmol/L
• 15% Clinisol - 1357 mOsmol/L
• 15% Plenamine - 1383 mOsmol/L
• Mixed with free water, dextrose and lipids to bring
down final concentration ~1400-2000 mOsmol/L
• Improved fluid balance
– Mobility of Extracellular fluid as amino acid infusion
changes osmotic pressure gradients and albumin
maintains osmotic pressure

11. Maintenance of osmotic pressure
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12. Cramping
• Approximately 20% of dialysis sessions are accompanied by muscle cramps
• Cramps are more pronounced in patients who require high ultrafitration
rates and are possibly dialyzed below their target weight.
• They are presumably related to reduction in muscle perfusion that occurs in
response to hypovolemia.
• Many of the treatment strategies are similar to those used to treat
intradialytic hypotension
• Immediate treatment is to increase intravascular volume by interrupting or
slowing ultrafiltration and administering saline
• Hypertonic solutions may directly improve blood flow to the muscles.
• Reassessment of the Target weight, counseling the patient to reduce
interdialytic weight gain
1. Wilkinson R, Barber SG, Robson V. Cramps, thirst and hypertension in hemodialysis patients -- The influence of dialyzate sodium concentration. Clin Nephrol 7:101-105, 1977
2. Brass EP, Adler S, Sietsema K, Amato A, Esler A, Hiatt WR. Peripheral arterial disease is not associated with an increased prevalence of intradialytic cramps in patients on maintenance hemodialysis. Am J Nephrol 22:491-496, 2002
3. Riely JD, Antony SJ. Leg cramps: Differential diagnosis and management. Am Fam Physician 52:1794-1798, 1995

13. 1) Potential impact of nutritional intervention on end-stage renal
disease hospitalization, death, and treatment costs -2007
• Lacson E, Ikizler A, Lazarus M, Teng M, Hakim RM.
• In this hypothetical scenario, increasing the
albumin by 0.2 g/dL had the potential to save
1400 lives, avert 6000 hospitalizations, and save
$36 million Medicare dollars
– Decreased Mortality
– Treatment Costs
– Decrease Hospitalization
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14. Mortality Indicator
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Three Month Average Albumin

15. Hospitalization
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16. Figure 1 Baseline serum albumin concentration and survival in patients on hemodialysis
Kalantar-Zadeh, K. et al. (2011) Diets and enteral supplements for improving outcomes in chronic kidney disease
Nat. Rev. Nephrol. doi:10.1038/nrneph.2011.60
Data obtained from Kalantar-Zadeh, K. et al. Nephrol. Dial. Transplant. 20, 1880–1888 (2005)
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17. 2) Severity of hypoalbuminemia predicts response to
intradialytic parenteral nutrition in hemodialysis patients -
2009
Areza Dezfuli, MD, Deborah Scholl, MS,RD, Stanley M. Lindenfeld, MD et al
• Prospective and contemporary cohort of 196 hypoalbuminemic MHD
patients who received IDPN (from Pentec) from 2002 – 2007 for 3 or
more months but not more than 12 months
• The IDPN formulas were very similar to ours
• Of the 196 patients, 72% responded to IDPN therapy; 28% were non
responders
• Of the responders, 59% of patients showed an improvement of serum
albumin of 0.5 g/dL or higher
• The average albumin level before IDPN was 2.68 g/dL
• IN this study, the serum albumin value increased by an average of 0.4
g/dL during the course of IDPN
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18. Severity of hypoalbuminemia predicts response to intradialytic
parenteral nutrition in hemodialysis patients -2009
• Patients with a serum albumin < 3 g/dL at baseline had
a 2.5 times higher chance of increasing the serum
albumin and a 3.8 times higher chance of increasing
the albumin by at least 0.5 g/dL.
• Patients with lower albumin levels will respond the
most dramatically to IDPN therapy.
• Total change in albumin level over 6 months 0.40 g/dL
• Diabetics responded well
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19. 3) The Use Of Intradialytic Parenteralnutrition In
Acutely Ill Haemodialysed Patients -2008
Korzets A., Azoulay O., Ori Y., Zevin D., Boaz M., Herman M., Chagnac
A., Gafter U
• 22 patients received IDPN for 1.5–17 months
• All studied parameters of nutrition and inflammation improved
significantly while patients were treated with IDPN.
• Increase in Protein catabolic rate (g protein/kg/day) 0.7 ± 0.2 to 1.2
± 0.2
• Increase in Albumin (g/l) 28 ± 5 to 38 ± 2
• Decrease c-RP (mg/l) 77 ± 86 to 9 ±10
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23. 4) Intradialytic parenteral nutrition (idpn) leads to sustained increase
of serum prealbumin (PA) levels in malnourished hemodialysis (HD)-
2012 Germany
T.A. Marsen, S. Degenhardt, C. Hoffmann, H. Mann.
• PreAlbumin is a nutritional parameter, positively correlated with
reduced morbidity and survival in malnourished HD patients. The study
addressed changes of PA during 16 weeks of IDPN in malnourished HD
patients. 107 malnourished HD patients albumin <35 g/l.
• Significant increase of PreAlbumin (SG: +26.31 mg/l vs CG: -1.84 mg/l)
• Diabetic patients revealed higher increase of PreAlbumin (SG: +32.62
mg/l vs CG: 1.67 mg/l)
• PreAlbumin elevation was maintained during 12w follow-up period
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24. 5) Nutrition support for the chronically wasted or acutely catabolic
chronic kidney disease patient -2009
• Ikizler TA Semin Nephrol. 2009;29:75-84.[Meta-analysis]
• Available evidence suggests that nutritional supplementation,
administered orally or parenterally, is effective in the treatment of
maintenance dialysis patients with protein-energy wasting in whom
oral dietary intake from regular meals cannot maintain adequate
nutritional stores. Increase serum albumin by 0.2 g/dL or greater
considerable improvements in mortality, Hospitalization, and treatment
costs.
– IDPN promoted a 96% increase in whole-body protein synthesis
– 50% decrease in whole body proteolysis (breakdown of proteins)
– Positive Nitrogen balance
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25. Control (White)
IDPN ( Grey)
PO (Black)
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26. 8 Month national Average 0.46
Increase in Albumin
2.99
3.14 3.16 3.25 3.27 3.24 3.27
3.40 3.45
2.00
2.50
3.00
3.50
4.00
Pre Start Alb 1 Alb 2 Alb 3 Alb 4 Alb 5 Alb 6 Alb 7 Alb 8
PCA Patient Average Albumin
N=103
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Internal Data collected from 2012-2013

27. 8 Month Regional Average 0.54
Increase in Albumin
2.79
2.98 2.96
3.10 3.18 3.14 3.08 3.13
3.33
2.00
2.50
3.00
3.50
4.00
Pre
Start
Alb 1 Alb 2 Alb 3 Alb 4 Alb 5 Alb 6 Alb 7 Alb 8
Average increase 0.54
N= 15
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Internal Data collected from 2012-2013

28. Anticipated Outcomes
• Nutrition Rehab Takes 3 To 9 Months
– Lab Values Increase In 3 Months On Average
– Weight and body composition Change In 6 To 12 Months
• “Why Don’t These Change?”
– Total Intake (Oral Diet + Idpn Or Ipn) Inadequate
– Co-morbidities Impact Outcomes –Diabetes, Lung and Heart
conditions, Cancer
– Chronic Inflammation secondary to Cardiac, Active Wounds,
Dental
– It Takes Time To Replete A Depleted Patient
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29. IDPN Formula Composition
• Basic formula
– Amino acids and dextrose
– Highly concentrated with AA
– Low volume
– Lipids
• Lower carbohydrate
– for patients with diabetes or glucose intolerance
– Does not require blood sugar checks
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30. IDPN Formulation
• Individualized to meet patient needs
• 5-8% Dextrose in IDPN provides enough sugar to metabolize AA and the staff
does not have to check blood glucose levels!
• Standard IDPN has(KDOQI)
– 1.2 to 1.4 g protein/kg
– 20 to 40 g dextrose
– 15 to 30 g lipid
• IDPN for a patient at 71-80 kg
– Amino Acids 100 gm 400 kcal
– Dextrose 35 gm 119 kcal
– Lipids 25 gm 250 kcal
– Total: 675-842 ml Total kcal = 769 kcal
– Without lipids 550-717 ml
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31. Reimbursement criteria
• Protein Malnutrition
– Three (3) consecutive months with Albumin levels below 3.4 gm/dl
• Energy Malnutrition
– Unintentionally maintained body mass index (BMI) < 20 with no upward trend
for the last three (3) months and/or documented unintentional weight loss >
5% of dry weight over last three (3) months or shorter period of time
– Documented lack of gain in dry weight despite intention to do so
– Dietitian has documented estimated caloric intake is less than needs based on
patient/caregiver reported intake and confirmed by dry weight loss
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Moore E, Lindenfield S. Intradialytic Parenteral Nutrition: A
Nutrition Support Intervention for High-risk Malnutrition in
Chronic Kidney Disease. Support Line. 2007;29(5):7-16
Pocket Guide to Nutritional Assessment of the Patient with
Chronic Kidney Disease, 4th Edition. 2009
T.A Marsen et.al/ Clinical Nutrition (2015) 1-11

32. Case Study
• 68 yo AA female, DM, HTN, tracheostomy,
multiple stage 2-3 decubitus ulcer, transport
via stretcher, non-ambulatory and LTAC.
• Large 6x8 cm stage IV with wound vacuum
• Admission nutrition labs, Albumin 2.1, Phos
1.8, Potassium 4.6, calcium 9, t-sats 22,hgb
8.1, ferritin 1433, Wt: 48.8kg
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33. Month 3
• IDPN initiated, 60gm AA, 23gm Dextrose,
433ml over 3 hours
• Alb: 2.1, 2.3, 2.2 Phos: 1.8, 2.4, 2.8, Wt: 45kg
• Non verbal response, 30% intake of oral
supplements Ensure
• Mechanical soft diet + 3 ensure/day
• 2L of continuous oxygen
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34. Month 6
• Alb: 2.2, 2.8, 2.6; IDPN: 80AA,23g Dextrose,
20gLipids, Wt: 49kg
• DC wound vac, pt getting out of bed to chair
3x/day
• 40% soft diet+oral supplements
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35. Month 9
• Alb: 2.6, 2.8, 2.6; IDPN: 80AA,23g Dextrose,
20gLipids, 620ml, Wt: 50.5 kg
• Wounds healing, patient now in wheel chair,
communicating, d/c trach
• No more stage 3-4 wounds, only 1-2 on the
back
• Appetite down to 30% intake of diet/oral
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36. Month 12
• Alb: 2.6, 2.4, 2.8; IDPN: 80AA,23g Dextrose,
20gLipids, 550ml, Wt: 52kg
• No more wounds, minor skin tear
• Ambulatory, DC from LTAC to Nursing home
• Soft diet + 3x boost
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37. Thank You
• Vishal Bagchi MBA, RD, LD
• Director of Medical and
Scientific Affairs
• Patient Care America
• M: 214-736-7969
• vbagchi@pcacorp.com
• http://www.linkedin.com/in/
vishalb3
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38. 38
1. Ikizler A, Nutrition Support For The Chronically Wasted Or Acutely Catabolic Chronic
Kidney Disease Patient; Seminars In Nephrology: Pp 75-84, January 2009
2. Dezfuli A, Scholl D, Lindenfeld SM, Kovesdy Cp, Kalantar-zadeh K, Severity Of
Hypoalbuminemia Predicts Response To Intradialytic Parenteral Nutrition In
Hemodialysis Patients, Journal Of Renal Nutrition : Pp 291–297, July 2009
3. Kumar R ,Dogra P, Kohok D, Pratt L, Pinzone A, Sridhar NR, Intradialytic Parenteral
Nutrition: Effect On Albumin And Normalized Protein Catabolic Rate; Am J Kidney
Dis. ;57(4):a55, 2011
4. Marsen TA, Fiedler R, Mann H Intradialytic Parenteral Nutrition (IDPN) Increases
Serum Prealbumin (PA) Levels In Malnourished Hemodialysis (HD) Patients,
Germany, ASN Conference, Philadelphia, PA November 2011
5. Cherry N, Shalansky K, Efficacy of Intradialytic Parenteral Nutrition in Malnourished
Hemodialysis Patients; American Journal of Health-System Pharmacy, October 2002
6. Korzets A., Azoulay O., Ori Y., Zevin D., Boaz M., Herman M., Chagnac A., Gafter U,
The Use Of Intradialytic Parenteralnutrition In Acutely Ill Haemodialysed Patients
Journal Of Renal Care 34(1), 14-18, 2008

39. 39
7. Cano NJM, Fouque D, Roth H, Aparicio M, Azar R, Canaud B, Et Al.
Intradialytic Parenteral Nutrition Does Not Improve Survival In
Malnourished Hemodialysis Patients: A 2-year Multicenter, Prospective,
Randomized Study. J Am Soc Nephrol. 2007;18:2583-2591.
8. Lacson E, Ikizler A, Lazarus M, Teng M, Hakim RM. Potential impact of
nutritional intervention on end-stage renal disease hospitalization, death,
and treatment costs. J Ren Nutr. 2007;17:363-371.
9. Tout D, Gibson S, Caughey A, Frassetto L. Intradialytic hyperalimentation as
adjuvant support in pregnant hemodialysis patients: case report and
review of the literature. International Urology and Nephrology. 2009;
Nov:1-8.
10. Joannidis M, Rauchenzauner M, Leiner B, Rosenkranz A, Ebenbichler CF,
Laimer M, et al. Effect of intradialytic parenteral nutrition in patients with
malnutrition-inflammation complex syndrome on body weight,
inflammation, serum lipids and adipocytokines: results from a pilot study.
Eur J Clin Nutr. 2008;62:789-795.

40. Importance of albumin
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