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临床试验/NCT02765009
NCT02765009已完成不适用

Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study

Central Hospital, Nancy, France8 个研究点 分布在 1 个国家目标入组 1,411 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,411
试验地点
8
主要终点
All-cause mortality at 60 days after inclusion

研究概览

简要总结

Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients under mechanical ventilation, admitted for > 48h and <72h and no discharge planned for the next 24h

排除标准

  • Age < 18 years
  • Failure to weigh the patient
  • Multiple trauma
  • Transfer from another ICU with a previous stay > 24h
  • High probability of withdrawing treatment for ethical purposes within 7 days
  • Pregnancy
  • Patient refusal

研究组 & 干预措施

Strategy

Experimental

Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)

干预措施: diuretics (Drug)

Strategy

Experimental

Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)

干预措施: albumin (Drug)

Strategy

Experimental

Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)

干预措施: fluid restriction (Other)

Strategy

Experimental

Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)

干预措施: renal replacement (Device)

结局指标

主要结局

All-cause mortality at 60 days after inclusion

时间窗: 60 days

Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected

次要结局

  • Fluid balance control at day 7(7 days)
  • Fluid balance control at day 14(14 days)
  • All-cause mortality at 28-day after inclusion(28 days)
  • Survival time period at Day 60(60 days)
  • All-cause in-hospital mortality(Up to 24 weeks)
  • All-cause mortality at 365 days after inclusion(365 days)
  • Survival time period at Day 365(365 days)
  • Global end-organ damage assessment(28 days)
  • Dependence on vasopressor drugs(28 days)
  • Dependence on mechanical ventilation(28 days)
  • Dependence on renal replacement therapy(60 days)
  • Cumulated number of pre-defined adverse events(14 days)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (8)

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