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

April 24, 2026 updated by: University of Alberta

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose: To primarily determine whether a lower CRRT dose-intensity in critically ill patients with acute kidney injury (AKI) is non-inferior to standard CRRT dose-intensity and to secondarily determined whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity.

Hypothesis: The primary hypothesis of the WISDOM trial is that lower CRRT dose-intensity is non-inferior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery. The secondary hypothesis of the WISDOM trial is that lower dose-intensity is superior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery.

Justification: No randomized controlled trial (RCT) to date has specifically evaluated the lower dose-intensity threshold for critically ill patients receiving CRRT. Specifically, there has been no specific evidence or guidance on the minimum dose-intensity targets for patients receiving CRRT. This is important for several reasons. First, CRRT is an invasive, resource intensive and expensive therapy. As such, there should be a concerted effort to minimize time on RRT and facilitate early recovery and weaning. Second, abundant evidence derived from secondary analyses have suggested that higher CRRT dose-intensity can propagate oliguria, prolong CRRT therapy and delay kidney recovery. This would imply that lower dose-intensity may facilitate kidney recovery and earlier weaning from CRRT. Third, there may be added implications of higher dose-intensity, including prolongation of non-renal organ support, such as delay in weaning from invasive mechanical ventilation. Fourth, evidence derived from observational registries show that lower CRRT dose-intensity, in the range proposed in this trial, provides comparable efficacy in azotemic, metabolic and acid-base homeostasis with similar outcomes. Observational data have suggested a prescribed CRRT dose-intensity of 15 mL/kg/hr may be sufficient for metabolic and azotemic control and is not associated with worse outcomes compared with guideline directed dose-intensity. This is lower quality evidence, however, implies that lower dose-intensity may be acceptable and safe. Fifth, it is plausible that following a short period of metabolic stabilization with CRRT, the minimum recommended CRRT dose-intensity of 20-25 mL/kg/hr may be excessive and have unmeasurable harm (e.g., excessive clearance of electrolytes, micronutrients, and medications [antimicrobials]). Finally, the prescription of a lower CRRT dose-intensity may have meaningful impact on reducing bedside nursing workload (e.g., fewer replacement solution bag changes) and reducing costs attributable to CRRT (e.g., lower effluent rates will reduce total replacement solution utilized).

While this proposal outlines a pilot feasibility trial, it is aimed at performing a larger rigorous RCT that will generate generalizable and high-quality evidence to impact clinical practice. The findings of the main phase of the WISDOM trial will provide clearer evidence to guide the prescription of a minimal dose-intensity for patients receiving CRRT. While this may be an effluent dose of 20-25 mL/kg/hr, it is entirely plausible that this will be a lower dose-intensity.

Objectives: The overall WISDOM trial program will address whether a lower CRRT dose-intensity in critically ill patients with AKI is non-inferior to standard CRRT dose-intensity and will secondarily address whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Continuous Renal Replacement Therapy (CRRT)
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).
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.
Device: Continuous Renal Replacement Therapy (CRRT)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in delivered CRRT dose-intensity
Time Frame: Through study completion, an average of 1 month.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - consent rate
Time Frame: Through study completion, at 90-days.
Consent rate for participation by patient or surrogate decision-maker (SDM).
Through study completion, at 90-days.
Feasibility - time to enrollment
Time Frame: During active recruitment into the trial, approximately 1 year.
Time from eligibility (e.g., starting RRT) to randomization.
During active recruitment into the trial, approximately 1 year.
Feasibility - adherence to prescribed CRRT dose-intensity
Time Frame: Through study completion, at 90-days.
Protocol adherence for allocated CRRT dose-intensity.
Through study completion, at 90-days.
Feasibility - ascertainment to delivered CRRT process measures
Time Frame: Through study completion, at 90-days.
Ability to capture delivered CRRT dose-intensity measures.
Through study completion, at 90-days.
Feasibility - outcome ascertainment
Time Frame: Through study completion, at 90-days.
Ability to capture patient and kidney endpoints at 90-days.
Through study completion, at 90-days.
Feasibility - recruitment rate
Time Frame: During active recruitment into the trial, approximately 1 year.
Ability to recruit 2 patients per site per month.
During active recruitment into the trial, approximately 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily bicarbonate while receiving CRRT, an average of 1 month.
Time Frame: Through study completion, at 90-days.
Physiological and biochemical outcomes.
Through study completion, at 90-days.
Daily serum phosphate while receiving CRRT, an average of 1 month
Time Frame: Through study completion, at 90-days.
Physiological and biochemical outcomes.
Through study completion, at 90-days.
Daily serum urea while receiving CRRT, an average of 1 month
Time Frame: Through study completion, at 90-days.
Physiological and biochemical outcomes.
Through study completion, at 90-days.
The total treatment time per day while receiving CRRT following randomization.
Time Frame: Through study completion, at 90-days.
Process of care measures.
Through study completion, at 90-days.
The proportion of hours of CRRT when the dose-intensity is in the target range following randomization.
Time Frame: Through study completion, at 90-days.
Process of care measures.
Through study completion, at 90-days.
Occurrence of adverse and serious adverse events.
Time Frame: Through study completion, at 90-days.
Safety measures.
Through study completion, at 90-days.
Occurrence of adverse events and serious adverse events leading to discontinuation of the trial intervention.
Time Frame: Through study completion, at 90-days.
Safety measures.
Through study completion, at 90-days.
RRT-free days at 90-days.
Time Frame: Through study completion, at 90-days.
Clinical Outcomes.
Through study completion, at 90-days.
The total number of hemofilter/circuit replacements while receiving CRRT following randomization.
Time Frame: Through study completion, at 90-days.
Process of care measures.
Through study completion, at 90-days.
The lowest and highest CRRT dose-intensity delivered for any given hour following randomization.
Time Frame: While receiving CRRT, an average of 1 month.
Process of care measures.
While receiving CRRT, an average of 1 month.
The total volume of replacement/dialysate fluid used per day following randomization.
Time Frame: Through study completion, at 90-days.
Process of care measures
Through study completion, at 90-days.
The total number of doses of supplemental electrolytes administered while receiving CRRT following randomization.
Time Frame: Through study completion, at 90 days.
Process of care measures
Through study completion, at 90 days.
The cumulative doses of supplemental electrolytes administered while receiving CRRT following randomization.
Time Frame: Through study completion, at 90 days.
Process of care measures
Through study completion, at 90 days.
The mean daily net ultrafiltration delivery while receiving CRRT following randomization.
Time Frame: Through study completion, at 90 days.
Process of care measures
Through study completion, at 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Sean M Bagshaw, MD, University of Alberta
  • Principal Investigator: Ron Wald, St. Michael's Hospital (Unity Health)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00140224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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