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

Primary Purpose

Acute Kidney Injury, Hypothermia

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Thermax Blood Warmer
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Kidney Injury focused on measuring continuous renal replacement therapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Prior to Thermax Warming

During warming

Post warming

Arm Description

Baseline temperature

Temperature during Thermax warming

Temperature after cessation of Thermax warming

Outcomes

Primary Outcome Measures

Temperature, accuracy
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius

Secondary Outcome Measures

Temperature, differences
Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax
Historic comparator
Using registry/PDMS data, how did the old blood warmer perform with regards to temperature

Full Information

First Posted
May 30, 2019
Last Updated
October 3, 2023
Sponsor
Karolinska University Hospital
Collaborators
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03973814
Brief Title
Hypothermia Risk With Continuous Renal Replacement Therapy
Acronym
HR-CRRT
Official Title
Hypothermia Risk With Continuous Renal Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Skane University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Hypothermia
Keywords
continuous renal replacement therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prior to Thermax Warming
Arm Type
Active Comparator
Arm Description
Baseline temperature
Arm Title
During warming
Arm Type
Active Comparator
Arm Description
Temperature during Thermax warming
Arm Title
Post warming
Arm Type
Active Comparator
Arm Description
Temperature after cessation of Thermax warming
Intervention Type
Device
Intervention Name(s)
Thermax Blood Warmer
Intervention Description
Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.
Primary Outcome Measure Information:
Title
Temperature, accuracy
Description
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Temperature, differences
Description
Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax
Time Frame
12-18 hours (six hour warming period)
Title
Historic comparator
Description
Using registry/PDMS data, how did the old blood warmer perform with regards to temperature
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (18-100 years) critically ill patients treated with CRRT. Exclusion Criteria: Patients under 18 years of age. Non-RRT patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Max Bell, MD, PhD
Phone
+46708278533
Email
max.bell@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Broman, MD, PhD
Phone
+46702898425
Email
ewert.broman@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Bell, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcus Broman, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Bell, MD, PhD
Phone
+46708278533
Email
max.bell@sll.se
First Name & Middle Initial & Last Name & Degree
Linn Hallqvist, MD
Phone
+46707716545
Email
linn.hallqvist@sll.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified patient and machine data may be made available after study completion, but this depends on the patent holder.
IPD Sharing Time Frame
Six months after study completion
IPD Sharing Access Criteria
Data access will be reviewed by the PI:s and research group.

Learn more about this trial

Hypothermia Risk With Continuous Renal Replacement Therapy

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