Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,350
- 试验地点
- 65
- 主要终点
- Mortality
研究概览
简要总结
Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.
The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.
详细描述
Critically ill patients in the ICU are at risk of stress related gastrointestinal (GI) bleeding, and SUP is recommended. However, the quantity and quality of evidence supporting SUP is low and has been questioned. Furthermore studies have shown that proton pump inhibitors (PPIs) may increase the risk of pneumonia, clostridium difficile infection and acute myocardial ischemia. The aim of the SUP-ICU trial is to assess the benefits and harms of SUP with PPI in adult critically ill patients in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute admission to the ICU
- •Age ≥ 18 years
- •One or more of the following risk factors:
- •Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg or lactate > 4 mmol/l)
- •Acute or chronic intermittent or continuous renal replacement therapy
- •Invasive mechanical ventilation which is expected to last > 24 hours
- •Coagulopathy (platelets < 50 x 109/l or international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours
- •Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)
- •History of coagulopathy (platelets < 50 x 109/l or INR > 1.5 or PT > 20 seconds) within 6 months prior to hospital admission
- •History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history)
排除标准
- •Contraindications to PPI
- •Ongoing treatment with PPI and/or H2RA on a daily basis
- •GI bleeding of any origin during current hospital admission
- •Diagnosed with peptic ulcer during current hospital admission
- •Organ transplant during current hospital admission
- •Withdrawal from active therapy or brain death
- •Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
- •Consent according to national regulations not obtainable
研究组 & 干预措施
Proton pump inhibitor (PPI)
Pantoprazole 40 mg
干预措施: Pantoprazole (Drug)
Normal saline
Saline (0.9%)
干预措施: Saline (0.9%) (Other)
结局指标
主要结局
Mortality
时间窗: 90 days
Landmark mortality 90-days after randomization
次要结局
- Number of Participants With Clinically Important GI Bleeding(Until ICU discharge, maximum 90 days)
- Number of Serious Adverse Reactions(Until ICU discharge, maximum 90 days)
- Percentage of Days Alive Without Organ Support(Within 90 days)
- Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia(Until ICU discharge, maximum 90 days)
- Number of Participants With One or More Infectious Adverse Events(Until ICU discharge, maximum 90 days)
- Mortality(1 year)
- A Health Economic Analysis(90 days)
研究者
Dr. Morten Hylander Møller
Principal investigator
Scandinavian Critical Care Trials Group