Clinical trial NCT05473143: Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy
Official title: Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Kidney Replacement
Critical Illness
Keywords: Fluid balance management
Ultrafiltration
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Admitted to the ICU
3. 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.
4. Planned initiation of KRT within the following 12 hours or the receipt of KRT for AKI for ≤48 hours

Exclusion Criteria:

1. 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
2. Probable discharge from the ICU within the next 48 hours according to treating physician
3. Severe burn injury (\>10% of body surface area)
4. Severe abnormality in serum sodium (\>155 or \<120 mmol/L)
5. Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids uring the next 48 hours
6. The clinical care team believes that the proposed intervention is inappropriate.

Primary outcomes:
measure: Cumulative fluid balance
timeFrame: From randomization to the end of day 5
Secondary outcomes:
measure: Feasibility: Ability to successfully enroll
timeFrame: During screening and enrolment
measure: Feasibility: Protocol adherence
timeFrame: From randomization to the end of day 5
measure: Feasibility: Ability to achieve follow-up
timeFrame: From randomization through day 90.
measure: Clinical: Death
timeFrame: From randomization through day 90.
measure: Clinical: Vasoactive therapy-free days
timeFrame: From randomization through day 28.
measure: Clinical: Mechanical ventilation-free days
timeFrame: From randomization through day 28.
measure: Clinical: KRT-free days
timeFrame: From randomization through day 28.
measure: Clinical: ICU-free days
timeFrame: From randomization through day 90
measure: Clinical: Hospital-free days
timeFrame: From randomization through day 90
measure: Dependence on KRT
timeFrame: within +/- 7 days of the 90-day time point following randomization.
measure: Resource use: cumulative time of continuous KRT
timeFrame: From randomization to the end of day 5
measure: Resource use: cumulative time of intermittent KRT
timeFrame: From randomization to the end of day 5
measure: Safety: Maximal vasopressor requirements
timeFrame: From randomization to the end of day 5
measure: Safety: Severity of illness
timeFrame: From randomization to the end of day 5
measure: Process measures: Target fluid balance as prescribed in the initial fluid balance prescription for the day
timeFrame: From randomization to the end of day 5
measure: Process measures: Proportion of time in which a neutral fluid balance target is selected by the clinical care team
timeFrame: From randomization to the end of day 5
measure: Process measures: Clinical elements used to assess fluid accumulation
timeFrame: From randomization to the end of day 5
measure: Process measures: The difference between the original target and the fluid balance achieved at the end of each 24-hour period
timeFrame: From randomization to the end of day 5
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: CHUM
name: William Beaubien-Souligny, MD PhD
role: STUDY_CHAIR
affiliation: Unity Health Toronto
name: Ron Wald, MDCM MPH
role: STUDY_CHAIR
affiliation: University of Alberta
name: Sean Bagshaw, MD MSc
role: STUDY_CHAIR
References: