Hypothermia Risk With Continuous Renal Replacement Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Temperature, accuracy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Temperature, accuracy
Time Frame: 24 hours
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius
Secondary Outcomes
- Temperature, differences(12-18 hours (six hour warming period))
- Historic comparator(24 hours)
Investigators
Max Bell
MD, PhD, Principal Investigator
Karolinska University Hospital