Critical Illness Clinical Trial
— Probe-FluidOfficial title:
Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 1, 2025 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative fluid balance | The difference between quantifiable fluid intake and output | From randomization to the end of day 5 | |
Secondary | Feasibility: Ability to successfully enroll | Target >30% of fully eligible patients | During screening and enrolment | |
Secondary | Feasibility: Protocol adherence | defined as >80% of participants adhering to the allocated treatment for 5 days after enrolment | From randomization to the end of day 5 | |
Secondary | Feasibility: Ability to achieve follow-up | Ability to achieve > 95% follow-up regarding all clinical outcomes | From randomization through day 90. | |
Secondary | Clinical: Death | Death from any cause | From randomization through day 90. | |
Secondary | Clinical: Vasoactive therapy-free days | A vasoactive-free day will be defined as = 2 hours of receipt of any vasoactive therapy provided by continuous infusion within a 24 hour period. Vasoactive therapy include norepinephrine, vasopressin, phenylephrine, epinephrine, dopamine >5mcg/kg/min, and angiotensin II. | From randomization through day 28. | |
Secondary | Clinical: Mechanical ventilation-free days | A ventilator-free day will be defined as the receipt of = 2 hours of mechanical ventilation within a 24-hour period. | From randomization through day 28. | |
Secondary | Clinical: KRT-free days | An KRT-free day will be defined receiving any KRT modality for = 2 hours within a 24 hours period. | From randomization through day 28. | |
Secondary | Clinical: ICU-free days | An ICU-free day will be defined as admission to an ICU for = 2 hours within a 24 hours period. | From randomization through day 90 | |
Secondary | Clinical: Hospital-free days | Hospital-free days will be defined as a 24-hour period completely free of an inpatient hospitalization. | From randomization through day 90 | |
Secondary | Dependence on KRT | KRT dependence will be defined by the receipt of any form of KRT | within +/- 7 days of the 90-day time point following randomization. | |
Secondary | Resource use: cumulative time of continuous KRT | Total cumulative duration in hours | From randomization to the end of day 5 | |
Secondary | Resource use: cumulative time of intermittent KRT | Total cumulative duration in hours | From randomization to the end of day 5 | |
Secondary | Safety: Maximal vasopressor requirements | Maximal vasopressor requirements as per the vasoactive-inotropic score recorded during each 24-hour period. | From randomization to the end of day 5 | |
Secondary | Safety: Severity of illness | Total sequential organ failure assessment (SOFA) score recorded during each 24-hour period. | From randomization to the end of day 5 | |
Secondary | Process measures: Target fluid balance as prescribed in the initial fluid balance prescription for the day | From randomization to the end of day 5 | ||
Secondary | 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 | ||
Secondary | Process measures: Clinical elements used to assess fluid accumulation | From randomization to the end of day 5 | ||
Secondary | 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 |
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