The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function in Critically Ill Adults With Intra-abdominal Hypertension and Acute Kidney Injury
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in IAP in patients receiving fluid removal during CVVH vs patients receiving CVVH without net fluid removal after 24 and 48h of CVVH treatment
研究概览
简要总结
Intra- abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are a cause of organ dysfunction in critically ill patients. IAH develops due to abdominal lesions (primary IAH) or extra-abdominal processes (secondary IAH). Secondary IAH arises due to decreased abdominal wall compliance and gut edema caused by capillary leak and excessive fluid resuscitation. Decreasing intra-abdominal pressure (IAP) using decompressieve laparotomy has been shown to improve organ dysfunction. However, laparotomy is generally avoided in patients with secondary IAH due to the risk of abdominal complications.
Acute kidney injury (AKI) is one of the first and most pronounced organ failures associated with IAH and many patients with AKI in the ICU require renal replacement therapy (RRT). Fluid removal using continuous RRT (CRRT) has been demonstrated to decrease IAP in small series and selected patients.
The aim of this study is to evaluate whether fluid removal using CVVH in patients with IAH, fluid overload and AKI is feasible and whether it has a beneficial effect on organ dysfunction (compared to CVVH without net fluid removal).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult patients (>18y old) of either gender
- •Admitted to the ICU
- •Sedated and mechanically ventilated (and expected to remain so for at least 48h)
- •Informed consent given
- •admitted to the ICU for <7 days or during the first 7 days of a new shock episode
- •AKI requiring RRT according to treating physician
- •IAP >12mmHg being attributed to fluid overload by treating physician
排除标准
- •Included in the same study before
- •Vasopressor and/or inotrope dose needed above noradrenaline 1µg/kg/min and dobutamine 10µg/kg/min
- •PaO2/FiO2 ratio <100
结局指标
主要结局
Change in IAP in patients receiving fluid removal during CVVH vs patients receiving CVVH without net fluid removal after 24 and 48h of CVVH treatment
时间窗: 24 and 48 hours
次要结局
- Difference between both groups in terms of daily fluid balance(during 7 days)
- Difference between both groups regarding mortality (28d, ICU and hospital) and ICU and hospital length of stay(28 days and length of stay in ICU and hospital)
- The relationship between cumulative fluid balance at the start of each day of CVVH and the fluid balance achieved after 24h of CVVH with fluid removal(24 hours)
- Difference between CVVH with fluid removal and CVVH without fluid removal(after 24 hours and/or 7 days)
- Difference between both groups regarding recovery of renal function, need for RRT at discharge from the ICU and from the hospital(discharge from ICU and hospital)