LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
University of Alberta
Study ID
NCT06446739
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Dialysis; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous Renal Replacement Therapy (CRRT) — DEVICE
    Continuous Renal Replacement Therapy (CRRT) is a continuous form of acute renal replacement (hemofiltration/dialysis) therapy provided to critically ill patients with multi-organ dysfunction receiving life support in the intensive care unit (ICU).

Study Details

An estimated 10-15% of critically ill patients with acute kidney failure in the intensive care unit receive acute dialysis therapy. The majority of these patients initially receive a continuous form of dialysis therapy call continuous renal replacement therapy (CRRT). Prior studies have suggested that higher CRRT dose-intensity improved health outcomes for these patients; however, this was not found in high-quality clinical trials. These more recent trials suggested a lower range of dose-intensity compared with the higher range as the new standard of care. This was incorporated into guidelines. To date, no clinical trials have evaluated this lower range and specifically, it is plausible that an even lower dose-intensity of CRRT may be well tolerated, safe, associated with similar outcomes and be more cost-effective. This is the objective of the WISDOM trial, to compare the guideline standard with lower dose-intensity among patients who are started on CRRT in the intensive care unit.

Key Dates

Start date
Nov 14, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low dose-intensity
    The intervention arm will consist of low dose-intensity CRRT, defined as the hourly delivery of a total effluent of 10-15 mL/kg/hr while receiving CRRT. The intervention dose-intensity is based on the rationale that 10-15 mL/kg/hr is the lower threshold of dose-intensity currently provided in clinical practice and prior observational data showing this threshold is tolerated and safe.
  • Active Comparator: Standard dose-intensity
    The control arm will receive a dose-intensity CRRT of 25-30 mL/kg/hr while receiving CRRT, aligned with local practice and information by international clinical practice guidelines. The control dose-intensity is based on the rationale that this is currently recommended in clinical practice guidelines and is commonly applied in routine practice.

Primary Outcome Measure

Difference in delivered CRRT dose-intensity [ Time Frame: Through study completion, an average of 1 month. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Kianoush Kashani, MD, MS
[email protected]
Mitchell Strand
[email protected]

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By research site
Mayo Clinic· Rochester, MN

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