Health Condition 1: O- Medical and Surgical
Conditions
Interventions
None listed
Sponsors
Fourrts India Laboratories Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with overt, occult, or clinically important gastrointestinal bleeding during ICU stay 2. Proportion of subjects with nosocomial or hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) during ICU stay 3. Proportion of subjects with Clostridium difficile infection during ICU stayTimepoint: Day 30 or Day of Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of ICU stay 2. Duration of stress-ulcer-free ICU stay 3. Duration of ICU stay free from mechanical ventilation or circulatory supportTimepoint: Baseline(Day1), End of study | — |
Countries
India
Contacts
Public ContactMr N Balasubramanian
Fourrts (India) Laboratories Pvt Ltd
Outcome results
None listed