HR-CRRT: Hypothermia Risk With Continuous Renal Replacement Therapy

Sponsor

Karolinska University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03973814

Collaborator

Skane University Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Hypothermia	Device: Thermax Blood Warmer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

The investigators will assess body temperature before-, during- and after Thermax blood warming treatment. Patients are essentially their own controls. Moreover, we will use historic data on the previous blood warmer for the Prismaflex device to assess temperature changes.The investigators will assess body temperature before-, during- and after Thermax blood warming treatment. Patients are essentially their own controls. Moreover, we will use historic data on the previous blood warmer for the Prismaflex device to assess temperature changes.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Hypothermia Risk With Continuous Renal Replacement Therapy

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Temperature, accuracy [24 hours]
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

Karolinska University Hospital
Skane University Hospital

Investigators

Principal Investigator: Max Bell, MD, PhD, Karolinska University Hospital
Principal Investigator: Marcus Broman, MD, PhD, Skane University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Max Bell, MD, PhD, Principal Investigator, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT03973814

Other Study ID Numbers:

BxIIRgrant

First Posted:

Jun 4, 2019

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Max Bell, MD, PhD, Principal Investigator, Karolinska University Hospital

continuous renal replacement therapy

Additional relevant MeSH terms:

Acute Kidney Injury

Hypothermia

Study Results

No Results Posted as of Mar 31, 2022