LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Renal Replacement Therapy (CRRT)
DeviceContinuous 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Low dose-intensityExperimental treatment 1 intervention
Group B: Standard dose-intensityActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 month.Secondary outcomes
1
Feasibility - consent rate
Consent rate for participation by patient or surrogate decision-maker (SDM).
Time frame
Through study completion, at 90-days.2
Feasibility - time to enrollment
Time from eligibility (e.g., starting RRT) to randomization.
Time frame
During active recruitment into the trial, approximately 1 year.3
Feasibility - adherence to prescribed CRRT dose-intensity
Protocol adherence for allocated CRRT dose-intensity.
Time frame
Through study completion, at 90-days.4
Feasibility - ascertainment to delivered CRRT process measures
Ability to capture delivered CRRT dose-intensity measures.
Time frame
Through study completion, at 90-days.Other outcomes
1
Daily bicarbonate while receiving CRRT, an average of 1 month.
Physiological and biochemical outcomes.
Time frame
Through study completion, at 90-days.2
Daily serum phosphate while receiving CRRT, an average of 1 month
Physiological and biochemical outcomes.
Time frame
Through study completion, at 90-days.3
Daily serum urea while receiving CRRT, an average of 1 month
Physiological and biochemical outcomes.
Time frame
Through study completion, at 90-days.4
The total treatment time per day while receiving CRRT following randomization.
Process of care measures.
Time frame
Through study completion, at 90-days.Sponsors and contacts
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Source ClinicalTrials.gov