Pantoprazole injection in preventing gastrointestinal bleeding as compared to saline

Phase 3

• Conditions: Health Condition 1: K252- Acute gastric ulcer with both hemorrhage and perforation

• Registration Number: CTRI/2022/09/045814
• Lead Sponsor: IMS and SUM hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
To compare efficacy and adverse events in-between pantoprazole prophylaxis versus placebo use <br/ ><br>•Clinically important GI bleed. <br/ ><br>•Overt GI bleed. <br/ ><br>•Pneumonia. <br/ ><br>•Clostridium difficile infection. <br/ ><br>•Acute myocardial ischemia. <br/ ><br>Timepoint: During ICU stay