Hypothermia Risk With Continuous Renal Replacement Therapy

Acute Kidney Injury Clinical Trial

— HR-CRRT  

Official title:

Hypothermia Risk With Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973814
• Other study ID #: BxIIRgrant
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: December 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypothermia

Intervention

Device:
• Thermax Blood Warmer
Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature, accuracy	During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius	24 hours
Secondary	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)
Secondary	Historic comparator	Using registry/PDMS data, how did the old blood warmer perform with regards to temperature	24 hours