SepsisNCT02706275
Pilot Trial of External Warming in Septic Patients
A study testing External warming in people with Sepsis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- External warming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 12 May 2019
- 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
- Admitted to a surgical or medical intensive care unit
- Age greater than 18 years
- Diagnosis of sepsis within 24 hours of enrollment
- Requirement for mechanical ventilation with expected duration of mechanical ventilation > 48 hours
- Goal Richmond Agitation Sedation Scale (RASS) < 0
- Maximum baseline temperature (within previous 24 hours) < 38.3°C
Who cannot join
- Treatment with chemotherapy within 6 months of enrollment
- Treatment with corticosteroids at a dose > 300 mg/day hydrocortisone (or equivalent)
- History of solid organ transplant on any immunosuppression medication
- History of immunological disease
- History of chronic infection with hepatitis B or C virus
- History of acute stroke, acute coronary syndrome, or severe head injury requiring osmotic therapy within 7 days prior to enrollment
Show all 10Show fewer
- History of multiple sclerosis
- Contraindications to both bladder or esophageal core temperature monitors or to forced air warming blankets
- Moribund status
- Sepsis without source control
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients
The purpose of this study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.
- Conditions
- Sepsis
- Being tested
- External warming
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External warmingOther
External warming via forced air warming to a goal body temperature 1.5°C greater than the baseline minimum temperature (within previous 24 hours) for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Warming Group | Experimental | External warming via forced air warming Receives: Other: External warming |
| Control Group | No intervention | Standard of care body temperature management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte human leukocyte antigen (mHLA-DR) expression
Measured: 48 hours hours following the start of the intervention period
Secondary outcomes (4)
Interferon (IFN)-gamma production
Measured: 48 hours following the start of the intervention period
Number of patients who acquire nosocomial infections
Number of patients who develop a nosocomial infection (defined as a new infection diagnosed greater than 48 hours after the original sepsis diagnosis) within 30 days of the sepsis diagnosis
Measured: 30 days after diagnosis of sepsis
Mortality
Measured: 28 days
Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention
Measured: Through study completion, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion12 May 2019
- Study completion12 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706275
- Sponsor's protocol ID
- 201512121
- Status last verified
- Apr 2020
- First submitted
- 1 Mar 2016
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Drewry AM, Mohr NM, Ablordeppey EA, Dalton CM, Doctor RJ, Fuller BM, Kollef MH, Hotchkiss RS. Therapeutic Hyperthermia Is Associated With Improved Survival in Afebrile Critically Ill Patients With Sepsis: A Pilot Randomized Trial. Crit Care Med. 2022 Jun 1;50(6):924-934. doi: 10.1097/CCM.0000000000005470. Epub 2022 Feb 7.
PubMed 35120040
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients
- ClinicalTrials.gov ID
- NCT02706275
- Acronym / sponsor ID
- 201512121
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 12 May 2019 (actual)
- First posted
- 11 Mar 2016 (estimated)
- 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 study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warming Group | Experimental | Other: External warmingExternal warming via forced air warming |
| Control Group | No intervention | –Standard of care body temperature management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to a surgical or medical intensive care unit
- Age greater than 18 years
- Diagnosis of sepsis within 24 hours of enrollment
- Requirement for mechanical ventilation with expected duration of mechanical ventilation > 48 hours
- Goal Richmond Agitation Sedation Scale (RASS) < 0
Key exclusion criteria (10 listed)
- Treatment with chemotherapy within 6 months of enrollment
- Treatment with corticosteroids at a dose > 300 mg/day hydrocortisone (or equivalent)
- History of solid organ transplant on any immunosuppression medication
- History of immunological disease
- History of chronic infection with hepatitis B or C virus
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 |
|---|---|---|
| External warmingExternal warming via forced air warming to a goal body temperature 1.5°C greater than the baseline minimum temperature (within previous 24 hours) for 48 hours | Other | Warming Group |
Primary outcome
Monocyte human leukocyte antigen (mHLA-DR) expression
Time frame: 48 hours hours following the start of the intervention period
4 secondary outcomes
Interferon (IFN)-gamma production
Time frame: 48 hours following the start of the intervention period
Number of patients who acquire nosocomial infections
Time frame: 30 days after diagnosis of sepsis
Mortality
Time frame: 28 days
Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention
Time frame: Through study completion, 2 years
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 28 Apr 2020.
- Derived from this study: PubMed 35120040Drewry AM, Mohr NM, Ablordeppey EA, Dalton CM, Doctor RJ, Fuller BM, Kollef MH, Hotchkiss RS. Therapeutic Hyperthermia Is Associated With Improved Survival in Afebrile Critically Ill Patients With Sepsis: A Pilot Randomized Trial. Crit Care Med. 2022 Jun 1;50(6):924-934. doi: 10.1097/CCM.0000000000005470. Epub 2022 Feb 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External warming in people with Sepsis, run by Washington University School of Medicine at 1 site 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 6 inclusion and 10 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 28 Apr 2020. 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 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 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?
Monocyte human leukocyte antigen (mHLA-DR) expression (time frame: 48 hours hours following the start of the intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706275, which also lists 1 linked publication.
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 28 Apr 2020.