Sup-Icu RENal (SIREN) - a Sub-analysis of the Prospective SUP (Stress Ulcer Prophylaxis)-ICU Trial on the Risk of GI- Bleeding in ICU Patients Receiving Renal Replacement Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,350
- 试验地点
- 2
- 主要终点
- The proportion of patients with clinically important GI bleeding
研究概览
简要总结
Data show that episodes of bleeding may often be observed in critically ill patients with dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD) may be considered a high risk population in regard to e.g. development of gastrointestinal (GI-) bleeding.
In the current prospective subanalysis "SIREN" of the randomized placebo-controlled clinical trial "SUP-ICU" (NCT02467621), the investigators seek to elucidate whether the subpopulation of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT) benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •please refer to SUP-ICU (NCT02467621) trial
排除标准
- •please refer to SUP-ICU (NCT02467621) trial
研究组 & 干预措施
Verum (pantoprazole)
干预措施: Pantoprazole (Drug)
Placebo
0.9% saline
干预措施: Saline 0.9% (matching placebo) (Drug)
结局指标
主要结局
The proportion of patients with clinically important GI bleeding
时间窗: 90 days or length of ICU stay, as applicable
次要结局
- Proportion of patients with serious adverse reactions(90 days or length of ICU stay, as applicable)
- Number of units of packed red blood cells (RBCs) transfused.(90 days or length of ICU stay, as applicable)
- 90-day/360-day/ ICU mortality rate in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/ placebo subgroups.(90 day, 360 days, or length of ICU stay, as applicable)
- 90-day and 1-year (365 days) mortality post-randomization(90 days/365 days or length of ICU stay, as applicable)
- Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling).(90 days or length of ICU stay, as applicable)
- Proportion of patients with one or more of the following adverse events: clinically important GI bleeding, pneumonia, C. difficile infection, or acute myocardial ischemia in the ICU(90 days or length of ICU stay, as applicable)
- Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU(90 days or length of ICU stay, as applicable)
- Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period(90 days or length of ICU stay, as applicable)
研究者
Jörg Schefold
SIREN principle investigator
Insel Gruppe AG, University Hospital Bern