OVMC Landmark trials series

1. RISK FACTORS FOR GASTROINTESTINAL
BLEEDING IN CRITICALLY ILL PATIENTS
OVMC LANDMARK TRIAL SERIES
COOK DJ, ET AL. "RISK FACTORS FOR
GASTROINTESTINAL BLEEDING IN CRITICALLY ILL
PATIENTS". THE NEW ENGLAND JOURNAL OF
MEDICINE. 1994. 330(6):337-381.

2. BACKGROUND
 Before this landmark
trial, use of PPI for stress
ulcer prophylaxis is
widespread in both ICU
and non-ICU patients,
despite lack of
indication
 Patients started on PPI
get continued on this
medication upon
discharge

3. SUBJECT
 In critically ill patients, what is the
incidence of significant GI bleed and
what are the risk factors that require GI
prophylaxis?

4. DESIGN
 Trial Design: Multicenter, prospective, observational study
 Location: Four academic ICUs
 Mean follow up: Not identified
 Subject=2,252
 Primary outcomes:
 Overt bleeding OR clinically important bleeding
 Overt bleeding (hematemesis, gross blood or “coffee grounds” material in a nasogastric
aspirate, hematochezia, or melena)
 Clinically important bleeding is defined as sBP drop 20 mmHg or HR increase 20 bpm;
Hgb drop 2g
 Of 2252 patients, 33 (1.5 percent; 95 percent confidence interval, 1.0 to 2.1 percent) had
clinically important bleeding.

5. INTERVENTION
 WITHOLD GI prophylaxis in all patients EXCEPT:
 Head injury
 Burns over >30% BSA
 Organ transplant recipients
 Diagnosis of gastritis in the previous 6 weeks
 Upper GI bleeding three to six weeks before admission
 Patients were followed for bleeding
 Prophylaxis options included H2 antagonists, antacids, sucralfate, prostaglandin analogues, and
omeprazole

6. CRITICISMS
 The study did not clearly define who was considered a critically ill patient (eg included CV
surgical patients who are at low risk for GI complications)
 Low rate of sepsis, cardiovascular, or respiratory disease as reason for ICU admissions
 Coagulopathy defined by elevation in fibrin-split products may better define the condition than
alterations in PT/aPTT as warfarin and heparin do not increase risk for GI bleeding

7. BOTTOM LINE
 Greatest risk factors for GI bleeding in
ICU patients are coagulopathy and
mechanical ventilation >48hours
 Incidence of clinically important
bleeding was less than 2% among
>2000 patients in this study
 Identifying risk of GI bleeding allows
more selective use of PPX against stress
ulcers, thus avoiding the unnecessary
exposure of patients to side effects of
PPX

8. GI PPX
Major risk (need 1)
• Coagulopathy (INR > 1.5, Plt < 50K, or
PTT > 2x normal)
• Mechanical ventilation > 48hrs
• GI ulceration or bleeding within the past
year
• Traumatic brain or spinal cord injury
• Severe burn (>35% of the body surface
area)
Minor Risk (need >2)
• Sepsis
• ICU stay > 1 week
• Occult GI bleeding > 6 days
• High dose glucocorticoid therapy
(>250mg hydrocortisone or equiv.)
• Enteral feeding (on case basis)

9. GI PROPHYLAXIS ON WARDS
 NOOONNNNEEEE!!!

10. DISCUSSION QUESTION
 What are the 2 most important risk factors for GI bleeding in ICU?
 Name 3 other risk factors for GI bleeding in ICU.
 What type of study is this?
 What is one criticism of this study?

11. CLINICAL APPLICATION: GI PPX OR NOT
 75yo w/ DM2, HTN, and ESRD on HD p/w left hip fracture, who was kept NPO for the past 3
days due to delaying in surgery schedule
 16 yo male w/ DM1 admitted to ICU for DKA secondary to non-compliance
 68 yo female w/ DMI2, HLD, and COPD p/w COPD exacerbation caused by community acquired
pneumonia requiring 5 day of intubation.
 36yo female w/ HIV and found to have CBS lymphoma started on low dose dexamethasone
and palliative brain radiation.
 59yo active drinker w/ hep C cirrhosis admitted for monitoring of withdrawal symptoms. INR
2.5, platelets 90, albumin 2.8, PTT normal ,and bilirubin 2.

12. REFERENCES
 Cook DJ, et al. "Risk factors for
gastrointestinal bleeding in critically ill
patients". The New England Journal of
Medicine. 1994. 330(6):337-381.
 Brain, L. P. (n.d.). GI bleeding in ICU
patients.
https://www.wikijournalclub.org/wiki/GI_bl
eeding_in_ICU_patients