Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Optimization Phase of Fluid Therapy in the Critically Ill (the RESPONSE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Change in individual mean cumulative urine output (mL/kg/h)
研究概览
简要总结
Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most common trigger to administer fluid bolus in a multinational practice survey in intensive care. The effect of fluid bolus on cardiovascular variables can be very short-lived among patients in shock suggesting that fluid boluses in the optimization phase are unlikely to improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor renal response to fluid bolus.
Objective: To investigate, whether fluid bolus - as a standard of care - improves urine output in oliguric patients compared to a non-interventional follow-up approach without fluid bolus.
Design: Investigator-initiated, open, randomized, controlled study
Interventions:
- Intervention group - follow-up without intervention
- Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes)
Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and sepsis
Trial size: 130 patients randomized in 2 ICUs
详细描述
Study hypothesis:
The investigators hypothesize that fluid bolus given due to oliguria does not improve urine output in a majority of patients, especially among those with acute kidney injury. Another study hypothesis is that patients receiving fluid bolus will have higher levels of endothelial damage biomarkers.
Intervention description:
Intervention group -follow-up without intervention; No intervention to increase the urine output within 2 hours will be done.
Standard group - Fluid bolus group: Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Emergency admission to an ICU
- •Mean arterial pressure (MAP) >65 mmHg (with vasopressors if needed) and initial fluid resuscitation for shock/hypovolemia has been given
- •Oliguria (urine output less than 0.5mL/kg/h) for at least 2 consecutive hours
排除标准
- •Marked fluctuations in hemodynamics within last 2 hours (cardiac arrhythmias, increase in norepinephrine need over 0.2ug/kg/min, need for initiation of inotrope/inodilator)
- •Administration of furosemide within last 6 hours
- •Chronic kidney disease (estimated pre-critical illness GFR < 60ml/min/1.73m2)
- •Renal replacement therapy
- •Among patients with acute kidney injury, urgent indications for commencing renal replacement therapy
- •Fluid overload (cumulative fluid accumulation exceeds 10% of baseline body weight)
- •Pulmonary edema (bilateral infiltrates in chest x-ray)
- •Active bleeding (need for transfusion, platelets, or fresh frozen plasma)
- •Suspected or known intra-abdominal hypertension (IAP >16mmHg)
- •Pregnant or lactating
- •Expected survival less than 24h
- •Obtaining informed consent is not possible/consent is denied
结局指标
主要结局
Change in individual mean cumulative urine output (mL/kg/h)
时间窗: 2 hours after randomization compared to urine output 2 hours preceding randomization
Doubling of the urine output is defined as clinically meaningful response
次要结局
- The difference between groups in the change in individual urine output(2 hours after randomization compared to urine output 2 hours preceding randomization)
- Duration of consecutive oliguria (urine output <0.5 mL/kg)(during ICU stay, i.e. as long as urine output stays below 0.5 mL/kg/h while the patient is in the ICU (an average of 5 to 7 days) or until renal replacement therapy is commenced)
- Cumulative fluid balance(six hours from randomization)
研究者
Suvi Vaara
MD, PhD
Helsinki University Central Hospital