Hypothermia Risk With Continuous Renal Replacement Therapy (HR-CRRT)

Karolinska University Hospital

Status: Completed

Conditions: Acute Kidney Injury; Hypothermia

Treatments: Device: Thermax Blood Warmer

Study type: Interventional

Funder types: Other

Identifiers

NCT03973814

BxIIRgrant

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Prior to Thermax Warming

Active Comparator group

Description:

Baseline temperature

Treatment:

Device: Thermax Blood Warmer

During warming

Active Comparator group

Description:

Temperature during Thermax warming

Treatment:

Device: Thermax Blood Warmer

Post warming

Active Comparator group

Description:

Temperature after cessation of Thermax warming

Treatment:

Device: Thermax Blood Warmer