Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood

NCT04103307 | Withdrawn Phase 2 DMC

• 1 other identifier: 113951
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Continuous Renal Replacement Therapy

Keywords

Cooling; CRRT

Outcome Measures

Primary Outcomes (1)

• Regional Wall Motion Abnormalities

  Number of segments undergoing a 20% reduction in longitudinal systolic strain

  At the end of delivery of cool blood during continuous dialysis; 12 to 24 hours

Secondary Outcomes (16)

• Regional Wall Motion Abnormalities at 7 days

  Seven days after the start of cool blood delivery during continuous dialysis

• Regional Wall Motion Abnormalities at ICU discharge

  At ICU discharge, an average of 60 days after the start of cool blood delivery during continuous dialysis

• Duration of Continuous Renal Replacement Therapy (CRRT)

  Through study completion, an average of 60 days

• Renal Recovery at 7 days after cool blood continuous dialysis requiring acute kidney injury

  Seven days after the start of cool blood delivery during continuous dialysis

• Renal Recovery at 24 hours after cool blood continuous dialysis requiring acute kidney injury

  24 hours after the start of cool blood delivery during continuous dialysis

Study Arms (2)

Control: Standard of care

NO INTERVENTION

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.

Intervention: Cooling

EXPERIMENTAL

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.

Procedure: Dialysis cooling

Interventions

Dialysis cooling PROCEDURE

Cooling the blood in the CRRT circuit during delivery

Intervention: Cooling

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Critical Care Trauma Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Marat Slessarev, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: The participants will receive CRRT in the form of CVVH or CVVHDF using the PrisMaxTM dialysis machine (Baxter Healthcare Corporation) according to local standard operating procedures. Filter anticoagulation will be maintained using either no anticoagulation, regional citrate or heparin. The TherMax™ blood warmer will be used when required to maintain a minimum body temperature. All participants will undergo CRRT via a temporary double-lumen hemodialysis catheter inserted into a central vein (internal jugular vein, subclavian vein, femoral vein). The standard of care entails continuous dialysis therapy for as long as deemed clinically necessary by the doctor. An external heater is used to rewarm the blood before delivering it back to the patient. If assigned to the intervention group, cool blood will be received during continuous dialysis. The cool blood will be delivered by having the heater set to 35.5°C.

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: September 25, 2019
• Study Start: November 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 31, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)