Health Condition 1: K252- Acute gastric ulcer with both hemorrhage and perforation
Conditions
Interventions
Intervention1: Pantoprazole: intravenous pantoprazole 40 mg once a day for 7days which is a proton pump inhibitor ,hypothesized to prevent stress related mucosal damage in mechanically ventilated pat
Sponsors
IMS and SUM hospital
Eligibility
Inclusion criteria
Inclusion criteria: All adult (18 years or older) patients who, will be getting ad-mitted to the critical care medicine ICU and mechanically ven-tilated and receiving enteral nutrition with one or more of the following risk factors for gastrointestinal bleeding: • Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure below 90 mmHg, mean arterial blood pressure below 70 mmHg or plasma lactate level 4 mmol/l or above). • Acute or chronic intermittent or continuous renal replace-ment therapy (RRT). • Invasive mechanical ventilation which is expected to last for more than 24 hours. • Coagulopathy (platelets below 50 × 109/l, or international normalized ratio (INR) above 1.5, or prothrombin time (PT) above 20 s [ documented within the last 24 hours]. • Ongoing treatment with anticoagulant drugs (prophylactic doses excluded). • History of coagulopathy (platelets below 50 × 109/l or INR above 1.5 or PT above 20 s (within the 6 months prior to hospital admission). • History of chronic liver disease (portal hypertension, cirrho-sis proven by biopsy, computed tomography (CT) scan or ul-trasound or history of variceal bleeding or hepatic encepha-lopathy)
Exclusion criteria
Exclusion criteria: • Contraindications to proton pump inhibitors: any history of intolerance to proton pump inhibitor or, treatment with anti HIV medication. • Ongoing treatment with proton pump inhibitors and/or histamine-2-receptor antagonists on a daily basis. Ongoing is defined as treatment not being discontinued at ICU admission Gastrointestinal bleeding of any origin (both upper and lower gastro-intestinal bleeding) during current hospi-tal admission, documented in the patient charts). • Diagnosed with peptic ulcer confirmed by en-doscopy or other method during current hospital admission. • Patient presenting with GI bleed or currently on-going GI bleed. • Organ transplant during current hospital admis-sion. • Withdrawal from active therapy or brain death documented in the patient charts. • Pregnancy. • Not giving consent. • Patients not mechanically ventilated • Patients not receiving enteral nutrition
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To compare efficacy and adverse events in-between pantoprazole prophylaxis versus placebo use • Clinically important GI bleed. • Overt GI bleed. • Pneumonia. • Clostridium difficile infection. • Acute myocardial ischemia. Timepoint: During ICU stay | — |
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of pantoprazole prophylaxis versus placebo for endoscopically confirmed stress related mucosal damage in mechanically ventilated ICU patients receiving enteral nutritionTimepoint: . After 6-8 days of admission or at the time of discharge from the ICU which-ever occurs earlier, upper GI endoscopy will be conducted at bedside to look for presence of stress related mucosal damage in both the groups of patients. | — |
Countries
India
Contacts
Public ContactRupali Patnaik
MICU
Outcome results
None listed