Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Kidney Injury
  • Hypothermia
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

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 PRISMAFL...

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.

Tracking Information

NCT #
NCT03973814
Collaborators
Skane University Hospital
Investigators
Principal Investigator: Max Bell, MD, PhD Karolinska University Hospital Principal Investigator: Marcus Broman, MD, PhD Skane University Hospital