Acute Kidney InjuryHR-CRRTNCT03973814
Hypothermia Risk With Continuous Renal Replacement Therapy
A study testing Thermax Blood Warmer in people with Acute Kidney Injury and Hypothermia, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury, Hypothermia
- What is being tested?
- Thermax Blood Warmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2022to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18-100 years) critically ill patients treated with CRRT.
Who cannot join
- Patients under 18 years of age. Non-RRT patients.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Hypothermia
- Being tested
- Thermax Blood Warmer
- Keywords
- continuous renal replacement therapy
- Medical subject headings
- Acute Kidney Injury, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermax Blood WarmerDevice
Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.
| Study group | Role | What they receive |
|---|---|---|
| Prior to Thermax Warming | Active comparator | Baseline temperature Receives: Device: Thermax Blood Warmer |
| During warming | Active comparator | Temperature during Thermax warming Receives: Device: Thermax Blood Warmer |
| Post warming | Active comparator | Temperature after cessation of Thermax warming Receives: Device: Thermax Blood Warmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature, accuracy
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius
Measured: 24 hours
Secondary outcomes (2)
Temperature, differences
Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax
Measured: 12-18 hours (six hour warming period)
Historic comparator
Using registry/PDMS data, how did the old blood warmer perform with regards to temperature
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Aug 2022
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Principal investigator, Max Bell, Karolinska University Hospital
- Investigators
- Max Bell, MD, PhD, Principal investigator, Karolinska University HospitalMarcus Broman, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973814
- Sponsor's protocol ID
- BxIIRgrant
- Acronym
- HR-CRRT
- Status last verified
- Dec 2023
- First submitted
- 30 May 2019
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified patient and machine data may be made available after study completion, but this depends on the patent holder.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia Risk With Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03973814
- Acronym / sponsor ID
- HR-CRRT / BxIIRgrant
- Conditions
- Acute Kidney Injury, Hypothermia
- Keywords
- continuous renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prior to Thermax Warming | Active comparator | Device: Thermax Blood WarmerBaseline temperature |
| During warming | Active comparator | Device: Thermax Blood WarmerTemperature during Thermax warming |
| Post warming | Active comparator | Device: Thermax Blood WarmerTemperature after cessation of Thermax warming |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18-100 years) critically ill patients treated with CRRT.
Key exclusion criteria (1 listed)
- Patients under 18 years of age. Non-RRT patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermax Blood WarmerPatients will be their own controls: Prior to-, during-, and after Thermax blood warming. | Device | During warming, Post warming, Prior to Thermax Warming |
Primary outcome
Temperature, accuracy
Time frame: 24 hours
During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius
2 secondary outcomes
Temperature, differences
Time frame: 12-18 hours (six hour warming period)
Historic comparator
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Yes. De-identified patient and machine data may be made available after study completion, but this depends on the patent holder.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Bell, MD, PhD principal investigator
Karolinska University Hospital
Marcus Broman, MD, PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermax Blood Warmer in people with Acute Kidney Injury and Hypothermia, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature, accuracy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.