Acute Kidney Injury Clinical Trial
— WISDOMOfficial title:
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM): A Pilot Randomized Trial
NCT number | NCT06446739 |
Other study ID # | 00140224 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | July 2025 |
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 continuous for 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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | July 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age > 18 years - clinical team decision to initiate CRRT associated with AKI - within 18 hours of commencement of CRRT - expected to 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 waiver of consent process is approved by local Research Ethics Board (REB). Exclusion Criteria: - absolute indication for higher dose-intensity CRRT - end-stage kidney disease receiving maintenance dialysis - inability to comply with the requirements of the study protocol. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Daily bicarbonate while receiving CRRT, an average of 1 month. | Physiological and biochemical outcomes. | Through study completion, at 90-days. | |
Other | Daily serum phosphate while receiving CRRT, an average of 1 month | Physiological and biochemical outcomes. | Through study completion, at 90-days. | |
Other | Daily serum urea while receiving CRRT, an average of 1 month | Physiological and biochemical outcomes. | Through study completion, at 90-days. | |
Other | The total treatment time per day while receiving CRRT following randomization. | Process of care measures. | Through study completion, at 90-days. | |
Other | The number of planned and unplanned hemofilter/circuit replacements while receiving CRRT following randomization. | Process of care measures. | Through study completion, at 90-days. | |
Other | The lowest and higher CRRT dose-intensity delivered for any given hour following randomization. | Process of care measures. | While receiving CRRT, an average of 1 month. | |
Other | The proportion of hours of CRRT when the dose-intensity is in the target range following randomization. | Process of care measures. | Through study completion, at 90-days. | |
Other | Occurrence of adverse and serious adverse events. | Safety measures. | Through study completion, at 90-days. | |
Other | Occurrence of adverse events and serious adverse events leading to discontinuation of the trial intervention. | Safety measures. | Through study completion, at 90-days. | |
Other | RRT-free days at 90-days. | Clinical Outcomes. | Through study completion, at 90-days. | |
Primary | Difference in delivered CRRT dose-intensity | This pilot trial will target detection of a minimum difference of 10 mL/kg/hr in delivered dose-intensity. | Through study completion, an average of 1 month. | |
Secondary | Feasibility - consent rate | Consent rate for participation by patient or surrogate decision-maker (SDM). | Through study completion, at 90-days. | |
Secondary | Feasibility - time to enrollment | Time from eligibility (e.g., starting RRT) to randomization. | During active recruitment into the trial, approximately 1 year. | |
Secondary | Feasibility - adherence to prescribed CRRT dose-intensity | Protocol adherence for allocated CRRT dose-intensity. | Through study completion, at 90-days. | |
Secondary | Feasibility - ascertainment to delivered CRRT process measures | Ability to capture delivered CRRT dose-intensity measures. | Through study completion, at 90-days. | |
Secondary | Feasibility - outcome ascertainment | Ability to capture patient and kidney endpoints at 90-days. | Through study completion, at 90-days. | |
Secondary | Feasibility - recruitment rate | Ability to recruit 2 patients per site per month. | During active recruitment into the trial, approximately 1 year. |
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