Recruiting

Low Dose-Intensity vs. Standard Dose-Intensity

Sponsor:

University of Alberta

Code:

NCT06446739

Conditions

Acute Kidney Injury

Dialysis; Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Renal Replacement Therapy (CRRT)

Study Details

Brief summary:

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.

Conditions

Acute Kidney Injury

Dialysis; Complications

Study ID

NCT06446739

Start date

Nov 14, 2024

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ellen Morrison, PhD

ejmorris@ualberta.ca

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kianoush Kashani, MD, MS

Kashani.Kianoush@mayo.edu

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 5A1

Contacts

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Grey Nuns Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Sturgeon Community Hospital

Recruiting

St. Albert, Alberta, Canada, T8N 6C4

Contacts

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada

Contacts

Maureen Meade, MD

meadema@mcmaster.ca

Sunnybrook Health Sciences Centre

Recruiting

North York, Ontario, Canada, M4N 3M5

Contacts

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Regina General Hospital/Saskatchewan Health Authority

Recruiting

Regina, Saskatchewan, Canada

Contacts

Bhanu Prasad, MBBS MRCP (UK) CCST FRCPC

bprasad@sasktel.net

More Information

Sponsor

University of Alberta

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • acute kidney injury
  • continuous renal replacement therapy
  • dose-intensity
  • randomized trial
  • pilot feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-07-09.