Hypothermia Risk With Continuous Renal Replacement Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypothermia Risk With Continuous Renal Replacement Therapy

Conditions
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Acute Kidney Injury, Hypothermia

Intervention / Treatment
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* Device: Thermax Blood Warmer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18-100 years) critically ill patients treated with CRRT. Exclusion Criteria: Patients under 18 years of age. Non-RRT patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prior to Thermax Warming<br>Baseline temperature | Device: Thermax Blood Warmer<br>* Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.<br>|
| Active Comparator: During warming<br>Temperature during Thermax warming | Device: Thermax Blood Warmer<br>* Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.<br>|
| Active Comparator: Post warming<br>Temperature after cessation of Thermax warming | Device: Thermax Blood Warmer<br>* Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature, accuracy | During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature, differences | Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax | 12-18 hours (six hour warming period) | 
| Historic comparator | Using registry/PDMS data, how did the old blood warmer perform with regards to temperature | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous renal replacement therapy