Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood

NCT ID: NCT04103307

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-12-31

Brief Summary

Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and is associated with longer hospital stays and worse survival. The mortality rate of critically ill patients in the ICU who receive renal replacement therapy for AKI ranges between 50-80%, cardiovascular disease being the second largest cause of death. A previous pilot study from the investigator's group showed that myocardial stunning occurs in AKI patients during continuous renal replacement therapy (CRRT) and may explain the high cardiovascular mortality in this population. In the chronic intermittent dialysis setting, mild dialysate cooling was shown to improve intradialytic hemodynamic stability and prevent myocardial stunning. The aim of this study is to find out whether cooling the blood in the CRRT circuit is an effective intervention to prevent myocardial stunning in AKI patients undergoing CRRT and improve patient outcomes.

Detailed Description

This is a single center, prospective, randomized, open label, controlled trial comparing standard-of-care temperature management with blood cooling CRRT. We will recruit approximately 140 patients (70 in each group) from the Medical Surgical Intensive Care Unit at University Hospital and The Critical Care Trauma Center at Victoria Hospital in London, Ontario.

The study team will randomize patients with acute kidney injury requiring continuous dialysis therapy into one of two groups; either to standard of care continuous dialysis therapy or to cool blood continuous dialysis therapy. All therapy will be delivered using the Baxter PrisMaxTM CRRT machine with TherMaxTM blood warmer.

All participants will undergo a series of echocardiograms (ultrasound of your heart) prior to continuous dialysis therapy initiation, 4-12 hours into therapy, for up to 7 days after therapy initiation, and at discharge from the intensive care unit. Blood work will be collected at 4 time points, prior to continuous dialysis therapy initiation, 4-12 hours into therapy, 24 hours into therapy, and at ICU discharge.

Hourly nasopharyngeal and skin temperatures will be collected. Oral temperature will be collected every four hours.

Conditions

Acute Kidney Injury; Continuous Renal Replacement Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control: Standard of care

Participants in the control group will receive standard-of-care CRRT prescriptions, and have the returning venous blood warmed with an external blood warmer to a temperature of 37°C. The blood warmer temperature will be adjusted by the CRRT nurse as per usual practice to maintain normothermia.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention: Cooling

Participants in the intervention group will receive standard of care CRRT prescriptions and have the blood warmer set to 35.5°C, as long as the nasopharyngeal temperature remains above 35.5°C.

Group Type: EXPERIMENTAL

Dialysis cooling

Intervention Type: PROCEDURE

Cooling the blood in the CRRT circuit during delivery

Interventions

Dialysis cooling

Cooling the blood in the CRRT circuit during delivery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• AKI as defined by 2012 AKI KDIGO guidelines requiring CRRT.
• Patient's core temperature between 35°C and 40°C at the time of recruitment.
• Age 18 years old and older.

Exclusion Criteria

• Hypothermia (patient core temperature <35°C) at the time of recruitment
• Extreme hyperthermia or hyperpyrexia (patient core temperature >40°C) at the time of recruitment.
• Contraindication to cooling (e.g., hemorrhagic shock or severe coagulopathy)
• Patients undergoing targeted temperature management for cardiac arrest.
• Chronic kidney disease stage 5 as defined by CKD KDIGO guidelines [19] requiring renal replacement therapy prior to recruitment.
• Receiving palliative care or immediate plans for withdrawal of life sustaining therapy at the time of recruitment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Marat Slessarev

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marat Slessarev, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Critical Care Trauma Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

113951

Identifier Type: -

Identifier Source: org_study_id