Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy
概览
- 阶段
- 不适用
- 干预措施
- Protocol-based fluid management
- 疾病 / 适应症
- Acute Kidney Injury
- 发起方
- Centre hospitalier de l'Université de Montréal (CHUM)
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cumulative fluid balance
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.
详细描述
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, thus making fluid removal a central component of the renal replacement therapy (KRT) prescription. Whereas the achievement and maintenance of euvolemia are critical objectives in the care of critically ill patients with severe AKI, there remain important knowledge gaps in our ability to effectively and safely deliver ultrafiltration. Multisystemic congestion resulting from fluid accumulation is believed to mediate adverse outcomes in this population and the timely use of mechanical fluid removal may improve prognosis. However, fluid removal may be associated with hemodynamic instability during KRT which may precipitate complications. The optimal fluid management strategy is currently unknown. The study is a pilot randomized clinical trial comparing a protocol-based fluid management strategy with usual care in critically ill patients receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. The protocol was designed to provide a standardized framework to prescribe fluid removal while allowing the attending care team to modify treatment targets according to their clinical evaluation. The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from randomization to 5 days. Feasibility will be documented including the ability to enroll the target population, protocol adherence, and the capacity to achieve follow-up through 90 days. Secondary outcomes will also include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
研究者
入排标准
入选标准
- •Age ≥ 18 years
- •Admitted to the ICU
- •AKI during current hospitalization defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria(1) as any of the following: Increase in serum creatinine by 27 µmol/L or more within any 48-hour window, or an increase in serum creatinine to 1.5 times baseline or more within the last 7 days, or a urine output less than 0.5 mL/kg/h for 6 hours.
- •Planned initiation of KRT within the following 12 hours or the receipt of KRT for AKI for ≤48 hours
排除标准
- •Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating physician
- •Probable discharge from the ICU within the next 48 hours according to treating physician
- •Severe burn injury (\>10% of body surface area)
- •Severe abnormality in serum sodium (\>155 or \<120 mmol/L)
- •Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids uring the next 48 hours
- •The clinical care team believes that the proposed intervention is inappropriate.
研究组 & 干预措施
Protocolized fluid removal
干预措施: Protocol-based fluid management
Usual care
干预措施: Usual care
结局指标
主要结局
Cumulative fluid balance
时间窗: From randomization to the end of day 5
The difference between quantifiable fluid intake and output
次要结局
- Clinical: Death(From randomization through day 90.)
- Clinical: KRT-free days(From randomization through day 28.)
- Process measures: Target fluid balance as prescribed in the initial fluid balance prescription for the day(From randomization to the end of day 5)
- Feasibility: Ability to achieve follow-up(From randomization through day 90.)
- Clinical: Vasoactive therapy-free days(From randomization through day 28.)
- Clinical: Hospital-free days(From randomization through day 90)
- Safety: Maximal vasopressor requirements(From randomization to the end of day 5)
- Clinical: Mechanical ventilation-free days(From randomization through day 28.)
- Clinical: ICU-free days(From randomization through day 90)
- Dependence on KRT(within +/- 7 days of the 90-day time point following randomization.)
- Resource use: cumulative time of continuous KRT(From randomization to the end of day 5)
- Process measures: Proportion of time in which a neutral fluid balance target is selected by the clinical care team(From randomization to the end of day 5)
- Feasibility: Ability to successfully enroll(During screening and enrolment)
- Feasibility: Protocol adherence(From randomization to the end of day 5)
- Process measures: The difference between the original target and the fluid balance achieved at the end of each 24-hour period(From randomization to the end of day 5)
- Resource use: cumulative time of intermittent KRT(From randomization to the end of day 5)
- Safety: Severity of illness(From randomization to the end of day 5)
- Process measures: Clinical elements used to assess fluid accumulation(From randomization to the end of day 5)