Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood

Acute Kidney Injury Clinical Trial

Official title:

Improving Outcomes in Patients Receiving Continuous Renal Replacement Therapy for Acute Kidney Injury by Cooling Blood in the Dialysis Circuit (CRRiTiCool): a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04103307
• Other study ID #: 113951
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Continuous Renal Replacement Therapy
• Wounds and Injuries

Intervention

Procedure:
• Dialysis cooling
Cooling the blood in the CRRT circuit during delivery

Locations

Country	Name	City	State
Canada	Critical Care Trauma Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Regional Wall Motion Abnormalities at 7 days	Number of segments undergoing a 20% reduction in longitudinal systolic strain after delivery of cool blood during continuous dialysis	Seven days after the start of cool blood delivery during continuous dialysis
Secondary	Regional Wall Motion Abnormalities at ICU discharge	Number of segments undergoing a 20% reduction in longitudinal systolic strain at ICU discharge	At ICU discharge, an average of 60 days after the start of cool blood delivery during continuous dialysis
Secondary	Duration of Continuous Renal Replacement Therapy (CRRT)	Number of hours of CRRT therapy during ICU admission	Through study completion, an average of 60 days
Secondary	Renal Recovery at 7 days after cool blood continuous dialysis requiring acute kidney injury	Renal recovery may best be defined as a reduction in AKI stage at seven days after the start of cool blood continuous dialysis treatment determined by creatinine level and urine output.	Seven days after the start of cool blood delivery during continuous dialysis
Secondary	Renal Recovery at 24 hours after cool blood continuous dialysis requiring acute kidney injury	Renal recovery may best be defined as a reduction in AKI stage at 24 hours after the start of cool blood continuous dialysis treatment determined by creatinine level and urine output.	24 hours after the start of cool blood delivery during continuous dialysis
Secondary	Low blood pressure	Systolic blood pressure less than 90mmHg or more than 20mmHg fall below baseline; 10% increase in vasopressor dose leading to an increase in blood pressure.	Through study completion, an average of 60 days
Secondary	Cumulative vasopressor dose	Dose of vasopressor drugs - unit dependent on drug	Through study completion, an average of 60 days
Secondary	Patient's Core Body Temperature (Celsius degrees)	Core body temperature as measured with SpotOn device	Through study completion, an average of 60 days
Secondary	Temperature of venous blood in return line (Celsius degrees)	Blood temperature measured with SpotOn device	Through study completion, an average of 60 days
Secondary	Intensive care unit free days	Number of days that a participant has been discharged from the ICU while admitted to the hospital	After an average of 60 days in the ICU
Secondary	ICU length of stay	Number of days a participant stayed in the ICU	Through study completion, an average of 60 days
Secondary	Hospital length of stay	Number of days a participant stayed in the hospital	Through study completion, an average of 60 days to hospital discharge
Secondary	ICU mortality	Mortality rate during ICU admission	Through study completion, an average of 60 days
Secondary	In Hospital Mortality	Mortality rate during in hospital stay	Through study completion, an average of 60 days to hospital discharge
Secondary	60-day Mortality	Mortality rate within the 60 day period	From study start to up to 60 days from study start
Secondary	Temperature correlation between nasopharyngeal, forehead, and oral temperature measurements	To correlate invasive measurements of core body temperature (nasopharyngeal) with non-invasive oral and forehead temperature monitoring using the SpotOn system	From study start to up to 60 days from study start