NCT03973814

Hypothermia Risk With Continuous Renal Replacement Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Kidney Injury
• Hypothermia

Interventions

Type	Name	Description
DEVICE	Thermax Blood Warmer	Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2019-06-04
• Last updated: 2023-12-22

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study