Hypothermia Risk With Continuous Renal Replacement Therapy (HR-CRRT)

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Hypothermia
• Intervention / Treatment: Device: Thermax Blood Warmer

Detailed Description

Blood warming devices during continuous renal replacement therapy (CRRT) have not been adequately tested.

The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.

Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been studied and one of the most common AE was hypothermia, reported in 44% of all cases.

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during CRRT as compared to the blood warmer used for the PrismaFlex system.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Max Bell, MD, PhD; Phone Number: +46708278533; Email: max.bell@sll.se
• Study Contact Backup: Name: Marcus Broman, MD, PhD; Phone Number: +46702898425; Email: ewert.broman@icloud.com

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult (18-100 years) critically ill patients treated with CRRT.

Exclusion Criteria:

• Patients under 18 years of age. Non-RRT patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prior to Thermax Warming; Baseline temperature	Device: Thermax Blood Warmer; Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.
Active Comparator: During warming; Temperature during Thermax warming	Device: Thermax Blood Warmer; Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.
Active Comparator: Post warming; Temperature after cessation of Thermax warming	Device: Thermax Blood Warmer; Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature, accuracy	During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature, differences	Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax	12-18 hours (six hour warming period)
Historic comparator	Using registry/PDMS data, how did the old blood warmer perform with regards to temperature	24 hours

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Skane University Hospital
• Investigators: Principal Investigator: Max Bell, MD, PhD, Karolinska University Hospital; Principal Investigator: Marcus Broman, MD, PhD, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: continuous renal replacement therapy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Body Temperature Changes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Hypothermia
• Other Study ID Numbers: BxIIRgrant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified patient and machine data may be made available after study completion, but this depends on the patent holder.
• IPD Sharing Time Frame: Six months after study completion
• IPD Sharing Access Criteria: Data access will be reviewed by the PI:s and research group.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes