Role of Active Deresuscitation After Resuscitation: The RADAR-Canada Pilot Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy: Mean cumulative fluid balance
研究概览
简要总结
The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU).
详细描述
Background: Over the course of an acute illness, critically ill patients typically receive substantial volumes of intravenous fluids, administered for resuscitation, maintenance, and as diluents for medications. A positive fluid balance is associated with adverse clinical outcomes. Whether active reversal of a positive fluid balance through fluid restriction and diuresis will improve outcomes is uncertain.
Methods: The Role of Active Deresuscitation After Resuscitation (RADAR) trial is a pilot study to determine the feasibility of a larger trial powered for clinically important outcomes, the acceptability of a deresuscitation protocol, and the impact of a trial on stability of practice patterns. RADAR is an open label pilot trial that will recruit 120 patients from 10 to 12 active sites in Canada. Eligible patients will be 18 years or older, mechanically ventilated >48 hours but in the ICU for less than five days, and in a calculated positive fluid balance of > three liters. Patients will be randomized to either usual care or a deresuscitation protocol incorporating a fluid minimization strategy and diuresis.
Results and Discussion: Evidence that recruited patients will be managed according to the trial protocol, with a withdrawal rate of less than 5%, a compliance rate of >75% and a crossover rate of <10% will establish the acceptability of the protocol. A mean difference in fluid balance between groups of more than three liters 72 hours after enrolment will establish the feasibility of the protocol. Analyses of clinical effects will be secondary analyses. Survival to day 90 following randomization will be measured, and other clinical measures will provide estimates of rates of key outcomes to inform the design of a definitive, adequately powered trial.
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)
盲法说明
Masking of the health care team will not be feasible as they must administer the intervention
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Mechanically ventilated for > 48 hours
- •Calculated volume accumulation > 3 liters since ICU admission or pitting edema in at least two sites (arms, legs, or trunk)
- •Admitted to ICU for ≤ five days
- •Informed consent obtained from patient or alternate decision-maker
排除标准
- •Lack of consent from patient or substitute decision maker or from responsible physician
- •Active bleeding (defined as > 2 units transfused RBC in past 24 hours)
- •Hemodynamic instability (defined as use of vasopressors >0.1 µg/kg/minute norepinephrine or equivalent, or increase in vasopressor dose over past 6 hours)
- •Currently receiving dialysis, or plans to initiate dialysis imminently
- •P/F ratio < 75
- •Subarachnoid hemorrhage
- •Severe traumatic brain injury with admission GCS <8
- •Diabetic ketoacidosis or hyperosmolar state
- •Acute cardiac failure or cardiogenic shock
- •Suspected or established diabetes insipidus
- •Allergy to furosemide
- •High probability of death within 24 hours
研究组 & 干预措施
Active deresuscitation
- Fluid minimization: clinical and research teams will review all intravenous orders and attempt to reduce fluids to 10-15 ml/hr.
- Active deresuscitation:
- Administer bolus furosemide 0.5 mg/kg bid or tid
- Target daily negative fluid balance as follows:
Calculated positive balance:
< 3 liters -600 - -800 ml/24 hours 3-6 liters 0.8 - 1.2 liters/24 hours 6- 10 liters 1.2 - 2.0 liters/24 hours >10 liters >2.0 liters/24 hours
- If bolus furosemide fails to achieve these goals, results in hypotension or tachycardia, or at the discretion of the attending intensivist, start furosemide infusion titrated on an hourly basis to achieve above goals
- If single agent ineffective, consider addition of metolazone
干预措施: Furosemide Injection (Drug)
Active deresuscitation
- Fluid minimization: clinical and research teams will review all intravenous orders and attempt to reduce fluids to 10-15 ml/hr.
- Active deresuscitation:
- Administer bolus furosemide 0.5 mg/kg bid or tid
- Target daily negative fluid balance as follows:
Calculated positive balance:
< 3 liters -600 - -800 ml/24 hours 3-6 liters 0.8 - 1.2 liters/24 hours 6- 10 liters 1.2 - 2.0 liters/24 hours >10 liters >2.0 liters/24 hours
- If bolus furosemide fails to achieve these goals, results in hypotension or tachycardia, or at the discretion of the attending intensivist, start furosemide infusion titrated on an hourly basis to achieve above goals
- If single agent ineffective, consider addition of metolazone
干预措施: Metolazone Tablets (Drug)
结局指标
主要结局
Efficacy: Mean cumulative fluid balance
时间窗: 72 hours following randomization
Total fluid input (mL) - output (mL) in each group
Compliance with deresuscitation protocol
时间窗: Each 24 hours over first week
Daily fluid balance in mL \>10 liters, target \>2.0 liters/24 hours
Acceptability of protocol
时间窗: Day 1
Percentage of eligible patients who consent to randomization
次要结局
- All cause mortality(90 days following randomization)
- New onset organ dysfunction(7 days following randomization)
- Organ support-free days(28 days following randomization)
研究者
John Marshall
Professor of Surgery and Critical Care Medicine
Unity Health Toronto