A Multicentric Observational Study to Assess the Effectiveness of Stress Ulcer Prophylaxis (SUP) with Pantoprazole and/or Sucralfate in Routine Critical Care Practice Settings.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1. Proportion of subjects with overt, occult, or clinically important gastrointestinal bleeding during ICU stay
研究概览
简要总结
A Multicentric, Observational trial in100 subjects in the age group of >=18years, admitted in ICU and require patoprazol and or sucralfate as prophylaxis for stress ulcer. The study will be conducted in 2 sites for a duration of up to 30days. Patients admitted in ICU and require patoprazol and or sucralfate as prophylaxis for stress ulcer will be informed about the study and asked if they wish to participate. Those participants who provide informed written consent , those data will be collected and analysed in the study. As this study is an observational study, so no intervention is there in the study. Only subject treatment details, complications, and lab investigations data will be collected from day 1 to upto 30 days of subject’s hospitalization or till subject’s discharge (whichever is earlier).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender aged ≥18 years
- •Admission to ICU within 4 days of study enrollment
- •Stress ulcer prophylaxis with pantoprazole and/or sucralfate
- •Willingness to provide written informed consent.
排除标准
- •On pantoprazole and/or sucralfate within 48 hours preceding the current ICU admission
- •Known allergy, hypersensitivity, proven inefficiency, or contraindications to any of the study medications
- •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.
结局指标
主要结局
1. Proportion of subjects with overt, occult, or clinically important gastrointestinal bleeding during ICU stay
时间窗: Day 30 or Day of Discharge
2. Proportion of subjects with nosocomial or hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) during ICU stay
时间窗: Day 30 or Day of Discharge
3. Proportion of subjects with Clostridium difficile infection during ICU stay
时间窗: Day 30 or Day of Discharge
次要结局
- 1. Duration of ICU stay(2. Duration of stress-ulcer-free ICU stay)