Effect of Sucralfate as a prophylactic agent for stress ulcer in ICU settings
Not Applicable
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/01/061168
- Lead Sponsor
- Fourrts India Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Subjects of either gender aged =18 years
2. Admission to ICU within 4 days of study enrollment
3. Stress ulcer prophylaxis with pantoprazole and/or sucralfate
4. Willingness to provide written informed consent
Exclusion Criteria
1. On pantoprazole and/or sucralfate within 48 hours preceding the current ICU admission
2. Known allergy, hypersensitivity, proven inefficiency, or contraindications to any of the study medications
3. Participation in another clinical trial within past 30 days
• Any other condition(s) or concomitant medication(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of subjects with overt, occult, or clinically important gastrointestinal bleeding during ICU stay <br/ ><br>2. Proportion of subjects with nosocomial or hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) during ICU stay <br/ ><br>3. Proportion of subjects with Clostridium difficile infection during ICU stayTimepoint: Day 30 or Day of Discharge
- Secondary Outcome Measures
Name Time Method 1. Duration of ICU stay <br/ ><br>2. Duration of stress-ulcer-free ICU stay <br/ ><br>3. Duration of ICU stay free from mechanical ventilation or circulatory supportTimepoint: Baseline(Day1), End of study