Comparing low and standard dose-intensity continuous renal replacement therapy in critically ill patients
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM): A Pilot Randomized Trial
This study is testing if a lower dose of kidney treatment is just as good as the standard dose for critically ill patients with acute kidney injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 9 sites (Rochester, Minnesota and 8 other locations) |
| Trial ID | NCT06446739 on ClinicalTrials.gov |
What this trial studies
The WISDOM trial aims to evaluate whether a lower dose-intensity of continuous renal replacement therapy (CRRT) is as effective as the standard dose-intensity for critically ill patients suffering from acute kidney injury (AKI). This interventional study will compare the outcomes of patients receiving lower dose-intensity CRRT against those receiving the standard guideline-directed dose. The primary goal is to determine if the lower dose is non-inferior in terms of CRRT duration and kidney recovery. Additionally, the study will assess if the lower dose can lead to shorter CRRT duration and improved recovery outcomes. This trial is significant as it addresses a gap in current clinical guidelines regarding the minimum effective dose of CRRT.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill adults aged 18 years and older who are expected to receive continuous renal replacement therapy for acute kidney injury.
Not a fit: Patients with end-stage kidney disease requiring maintenance dialysis or those needing higher dose-intensity CRRT will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more cost-effective and less invasive treatment options for critically ill patients with acute kidney injury.
How similar studies have performed: While previous studies have explored CRRT dose-intensity, this trial is novel as it specifically investigates the lower dose-intensity threshold, which has not been previously evaluated in randomized controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 18 years * weight ≥ 55 kg * plan to initiate CRRT or within 24 hours of having started CRRT for AKI * expected to survive and receive CRRT for a duration of ≥ 48 hours * able to provide informed consent or have an authorized representative provide consent after being informed on the details and risks of the trial unless a deferred consent process is approved by local Research Ethics Board (REB). Exclusion Criteria: * indication for sustained higher dose-intensity CRRT as designated by the attending clinicians * end-stage kidney disease receiving maintenance dialysis * receipt of any RRT for AKI during the current hospitalization * inability to comply with the requirements of the study protocol.
Where this trial is running
Rochester, Minnesota and 8 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
- Grey Nuns Hospital — Edmonton, Alberta, Canada (Recruiting)
- Sturgeon Community Hospital — St. Albert, Alberta, Canada (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Centre — North York, Ontario, Canada (Recruiting)
- St Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Regina General Hospital/Saskatchewan Health Authority — Regina, Saskatchewan, Canada (Recruiting)
- Guy's & St Thomas' Hospitals — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sean M Bagshaw, MD — University of Alberta
- Study coordinator: Sean M Bagshaw, MD
- Email: bagshaw@ualberta.ca
- Phone: 780-248-1256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.