SepsisWARMTHNCT04961151
Working Toward the Advancement of Recovery Using Modulated Therapeutic Hyperthermia (WARMTH) in Sepsis - Pilot
A study testing Multimodal therapeutic warming w/ esophageal d/c and Multimodal therapeutic warming w/ conductive d/c in people with Sepsis, run by Nicholas M Mohr at 3 sites in United States.
Trial summary
The purpose of this pilot study is to demonstrate the ability to warm critically ill patients with sepsis to a target temperature of 39°C Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Multimodal therapeutic warming w/ esophageal d/c and Multimodal therapeutic warming w/ conductive d/c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Aug 2021to 1 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18 years old.
- Patients with sepsis diagnosed within 48 hours of enrollment. For the purpose of this protocol, sepsis onset is defined as administration of intravenous antibiotics in a patient that the treating critical care physician feels is ill from sepsis.
- All qualifying patients must have a sequential organ failure assessment (SOFA) score of 2 or greater at the time of enrollment.
- Patients requiring mechanical ventilation with an expected duration of mechanical ventilation of >= 2 days.
- Patient maximum baseline documented temperature (within previous 24 hours) < 38.3°C.
Who cannot join
- Patients without legally authorized representative able to provide informed consent.
- Patients with contraindication to core warming using an esophageal core warming device, surface warming using conductive heat transfer, and forced air warmer.
- Patients known to be pregnant.
- Patients with <40 kg of body mass.
- Patients with comfort care only status.
- Patients with contraindications to hyperthermia treatment (acute stroke, acute traumatic brain injury, acute spinal cord injury, post-cardiac arrest, multiple sclerosis, or sickle cell disease).
- Expected continuous dialysis within 48 hours after enrollment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Washington University
St Louis, Missouri, 63130
About this study
The purpose of this pilot study is to demonstrate the ability to warm critically ill patients with sepsis to a target temperature of 39°C
Read the detailed description
Participants with sepsis and without fever will be warmed with surface (forced air and conductive wraps) and core (esophageal) warming, and will have the warming devices placed in the ICU. The warming devices will remain in place until the study is completed (36 hours). The heat exchangers will be set to attain a patient target temperature of 39°C as rapidly as possible, after which the forced-air (non-servo) system will be removed, and the conductive system heat exchanger (powering the water blankets and esophageal device, both of which are servo-controlled) will be set to maintain patient temperature at 39°C for the duration of the study period.
Once goal temperature has been achieved for 2 consecutive hours, the forced air warming device will be discontinued. Patients will be randomized at this point to Group 1, in which esophageal warming will be discontinued first or to Group 2, in which external conductive warming will be discontinued first.
All patients will have usual standard of care labs, vital signs, and imaging for patients undergoing mechanical ventilation in the ICU. For the duration of the 36-hour intervention, patient vital signs, including blood pressure, heart rate, respiratory rate, and vasopressor requirements will be monitored and recorded every 6 hours. Core temperature will be measured and recorded hourly.
Patient's clinical status and outcome will be reviewed in the medical chart 7 days after study completion.
- Conditions
- Sepsis
- Being tested
- Multimodal therapeutic warming w/ esophageal d/c, Multimodal therapeutic warming w/ conductive d/c
- Keywords
- hyperthermia, fever, sepsis
- Medical subject headings
- Sepsis, Hyperthermia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal therapeutic warming w/ esophageal d/cOther
In order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, esophageal warming will be discontinued.
Multimodal therapeutic warming w/ conductive d/cOther
In order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, conductive warming will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Conductive Wrap Warming | Experimental | Esophageal warming will be discontinued first Receives: Other: Multimodal therapeutic warming w/ esophageal d/c |
| Esophageal Warming | Experimental | Conductive wraps will be discontinued first Receives: Other: Multimodal therapeutic warming w/ conductive d/c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of warming critically ill patients with sepsis using a multimodal sepsis warming protocol.
Our primary outcome is the proportion of patients who achieve goal temperature within 6 hours of starting warming. After discontinuing devices, we will monitor the proportion of participants who remain at the goal temperature.
Warming will be performed using standard technique per instructions for use for the surface warming wraps, esophageal heat transfer device, and forced air warming device. The heat exchanger will be set to a target patient temperature of 39°C, with patient temperature measured via temperature sensing Foley catheter or rectal temperature sensor. Feedback (servo) control is provided by the heat exchanger (Blanketrol III, Gentherm Medical, Cincinnati, OH), such that the water temperature flow through the warming devices is adjusted automatically to enable attainment of the target temperature. Forced air warming will be used until goal temperature is reached for at least 2 hours, then other devices will be used to maintain temperature.
Measured: 36 hours
Secondary outcomes (2)
Determine the rate of temperature change of patients undergoing a sepsis warming protocol.
Participants will be initiated on a warming protocol with forced air warming, surface conductive, and esophageal core warming with the target temperature of 39°C. Patient temperature measurement will be collected hourly during the study period (36 hours).
Measured: 36 hours
Determine the ability of conductive heat wraps vs. conductive esophageal device to maintain therapeutic hyperthermia
Once goal temperature has been achieved for 2 consecutive hours, the forced air warming device will be discontinued. Participants will be randomized at this point to Group 1, in which esophageal warming will be discontinued first or to Group 2, in which external conductive warming will be discontinued first.
Once goal temperature has been achieved for 4 consecutive hours after discontinuation of the forced air warming device, the second device will be discontinued. If patient body temperature drops below goal temperature, the second warming device will be restarted to maintain temperature.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start25 Aug 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas M Mohr
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, Washington University School of Medicine
- Responsible party
- Sponsor-investigator, Nicholas M Mohr, University of Iowa
- Investigators
- Nicholas Mohr, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961151
- Sponsor's protocol ID
- H202104263
- Acronym
- WARMTH
- Status last verified
- Nov 2022
- First submitted
- 25 Jun 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Toward the Advancement of Recovery Using Modulated Therapeutic Hyperthermia (WARMTH) in Sepsis - Pilot
- ClinicalTrials.gov ID
- NCT04961151
- Acronym / sponsor ID
- WARMTH / H202104263
- Conditions
- Sepsis
- Keywords
- hyperthermia, fever, sepsis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nicholas M MohrUniversity, hospital or other
- Collaborators
- Hennepin County Medical Center, Minneapolis, Washington University School of Medicine
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 Jul 2021 (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 purpose of this pilot study is to demonstrate the ability to warm critically ill patients with sepsis to a target temperature of 39°C
Detailed description
Participants with sepsis and without fever will be warmed with surface (forced air and conductive wraps) and core (esophageal) warming, and will have the warming devices placed in the ICU. The warming devices will remain in place until the study is completed (36 hours). The heat exchangers will be set to attain a patient target temperature of 39°C as rapidly as possible, after which the forced-air (non-servo) system will be removed, and the conductive system heat exchanger (powering the water blankets and esophageal device, both of which are servo-controlled) will be set to maintain patient temperature at 39°C for the duration of the study period.
Once goal temperature has been achieved for 2 consecutive hours, the forced air warming device will be discontinued. Patients will be randomized at this point to Group 1, in which esophageal warming will be discontinued first or to Group 2, in which external conductive warming will be discontinued first.
All patients will have usual standard of care labs, vital signs, and imaging for patients undergoing mechanical ventilation in the ICU. For the duration of the 36-hour intervention, patient vital signs, including blood pressure, heart rate, respiratory rate, and vasopressor requirements will be monitored and recorded every 6 hours. Core temperature will be measured and recorded hourly.
Patient's clinical status and outcome will be reviewed in the medical chart 7 days after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conductive Wrap Warming | Experimental | Other: Multimodal therapeutic warming w/ esophageal d/cEsophageal warming will be discontinued first |
| Esophageal Warming | Experimental | Other: Multimodal therapeutic warming w/ conductive d/cConductive wraps will be discontinued first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients above the age of 18 years old.
- Patients with sepsis diagnosed within 48 hours of enrollment. For the purpose of this protocol, sepsis onset is defined as administration of intravenous antibiotics in a patient that the treating critical care physician feels is ill from sepsis.
- All qualifying patients must have a sequential organ failure assessment (SOFA) score of 2 or greater at the time of enrollment.
- Patients requiring mechanical ventilation with an expected duration of mechanical ventilation of >= 2 days.
- Patient maximum baseline documented temperature (within previous 24 hours) < 38.3°C.
Key exclusion criteria (7 listed)
- Patients without legally authorized representative able to provide informed consent.
- Patients with contraindication to core warming using an esophageal core warming device, surface warming using conductive heat transfer, and forced air warmer.
- Patients known to be pregnant.
- Patients with <40 kg of body mass.
- Patients with comfort care only status.
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 |
|---|---|---|
| Multimodal therapeutic warming w/ esophageal d/cIn order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, esophageal warming will be discontinued. | Other | Conductive Wrap Warming |
| Multimodal therapeutic warming w/ conductive d/cIn order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, conductive warming will be discontinued. | Other | Esophageal Warming |
Primary outcome
Feasibility of warming critically ill patients with sepsis using a multimodal sepsis warming protocol.
Time frame: 36 hours
Our primary outcome is the proportion of patients who achieve goal temperature within 6 hours of starting warming. After discontinuing devices, we will monitor the proportion of participants who remain at the goal temperature. Warming will be performed using standard technique per instructions for use for the surface warming wraps, esophageal heat transfer device, and forced air warming device. The heat exchanger will be set to a target patient temperature of 39°C, with patient temperature measured via temperature sensing Foley catheter or rectal temperature sensor. Feedback (servo) control is provided by the heat exchanger (Blanketrol III, Gentherm Medical, Cincinnati, OH), such that the water temperature flow through the warming devices is adjusted automatically to enable attainment of the target temperature. Forced air warming will be used until goal temperature is reached for at least 2 hours, then other devices will be used to maintain temperature.
2 secondary outcomes
Determine the rate of temperature change of patients undergoing a sepsis warming protocol.
Time frame: 36 hours
Determine the ability of conductive heat wraps vs. conductive esophageal device to maintain therapeutic hyperthermia
Time frame: 36 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Integrated Medicine for Sepsis: An RCT With Phenotyping
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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.
Nicholas Mohr, MD principal investigator
University of Iowa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal therapeutic warming w/ esophageal d/c and Multimodal therapeutic warming w/ conductive d/c in people with Sepsis, run by Nicholas M Mohr at 3 sites in United States.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of warming critically ill patients with sepsis using a multimodal sepsis warming protocol. (time frame: 36 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 14 Nov 2022.