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Hypothermia Risk With Continuous Renal Replacement Therapy

Hypothermia Risk With Continuous Renal Replacement Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03973814
Acronym
HR-CRRT
Enrollment
100
Registered
2019-06-04
Start date
2022-08-01
Completion date
2023-12-21
Last updated
2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Hypothermia

Keywords

continuous renal replacement therapy

Brief 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.

Interventions

DEVICEThermax Blood Warmer

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

Sponsors

Skane University Hospital
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Temperature, accuracy24 hoursDuring use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius

Secondary

MeasureTime frameDescription
Temperature, differences12-18 hours (six hour warming period)Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax
Historic comparator24 hoursUsing registry/PDMS data, how did the old blood warmer perform with regards to temperature

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026