Hypothermia Risk With Continuous Renal Replacement Therapy

Last updated: December 21, 2023
Sponsor: Karolinska University Hospital
Overall Status: Completed

Phase

N/A

Condition

Kidney Disease

Kidney Failure

Renal Failure

Treatment

Thermax Blood Warmer

Clinical Study ID

NCT03973814
BxIIRgrant
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Thermax Blood Warmer
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
December 21, 2023

Study 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.

Connect with a study center

  • Karolinska University Hospital

    Stockholm, 17176
    Sweden

    Site Not Available

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