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

NCT06446739 | Recruiting FDA Device

• 1 other identifier: 00140224
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 9

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

Keywords

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

Outcome Measures

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.

  Through study completion, an average of 1 month.

Secondary Outcomes (6)

• Feasibility - consent rate

  Through study completion, at 90-days.

• Feasibility - time to enrollment

  During active recruitment into the trial, approximately 1 year.

• Feasibility - adherence to prescribed CRRT dose-intensity

  Through study completion, at 90-days.

• Feasibility - ascertainment to delivered CRRT process measures

  Through study completion, at 90-days.

• Feasibility - outcome ascertainment

  Through study completion, at 90-days.

Other Outcomes (14)

• Daily bicarbonate while receiving CRRT, an average of 1 month.

  Through study completion, at 90-days.

• Daily serum phosphate while receiving CRRT, an average of 1 month

  Through study completion, at 90-days.

• Daily serum urea while receiving CRRT, an average of 1 month

  Through study completion, at 90-days.

Study Arms (2)

Low dose-intensity

EXPERIMENTAL

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)

Standard dose-intensity

ACTIVE COMPARATOR

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)

Interventions

Continuous Renal Replacement Therapy (CRRT) DEVICE

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).

Low dose-intensity; Standard dose-intensity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (9)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Grey Nuns Hospital

Edmonton, Alberta, Canada

RECRUITING

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

RECRUITING

Sunnybrook Health Sciences Centre

North York, Ontario, M4N 3M5, 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, SE1 9RT, United Kingdom

RECRUITING

Related Publications (1)

• Beaubien-Souligny W, Thompson Bastin M, Teixeira JP, Cerda J, Connor MJ Jr, Dijanic Zeidman A, Garimella PS, Juncos L, Lopez-Ruiz A, Mehta R, Reis T, Rizo-Topete L, Silver SA, Da Silva JR, Speer R, Vijayan A, Wells C, Wille K, Yessayan L, Tolwani A, Neyra JA. Proceedings of the University of Alabama at Birmingham Continuous Renal Replacement Therapy Academy (2023-2024): Managing De-Escalation of Acute Renal Replacement Therapy and Optimizing Drug Dosing during Renal Replacement Therapy Transitions. Kidney360. 2025 Oct 1;6(10):1798-1809. doi: 10.34067/KID.0000000951. Epub 2025 Aug 8.

  PMID: 40779331 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Sean M Bagshaw, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Ron Wald

  St. Michael's Hospital (Unity Health)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean M Bagshaw, MD

CONTACT

780-248-1256; bagshaw@ualberta.ca

Ellen Morrison, PhD

CONTACT

ejmorris@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: June 6, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CA (7); GB (1); US (1)