HypothermiaSHIVERNCT02339103
Study of Heat and Intravenous Fluids for Exogenous Rewarming
A study testing Warmed IV fluids and Warmed perfusion pads in people with Hypothermia, run by Stanford University.
Trial summary
The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Warmed IV fluids and Warmed perfusion pads
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any healthy male or female over 18 years of age
Who cannot join
- No heart/blood pressure/cholesterol medications.
- No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion
About this study
Official title: Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)
The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.
- Conditions
- Hypothermia
- Being tested
- Warmed IV fluids, Warmed perfusion pads
- Keywords
- arteriovenous anastomoses, accidental hypothermia, rewarming
- Medical subject headings
- Hypothermia, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed IV fluidsOther
1 Liter of warmed IV fluids at 42 degrees celsius
Warmed perfusion padsOther
Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses
| Study group | Role | What they receive |
|---|---|---|
| Shivering only | No intervention | Pt placed in sleeping bag and warmed by shivering only |
| Warmed IV fluids | Experimental | 2 Liter of 42 degree celsius normal saline Receives: Other: Warmed IV fluids |
| Warmed perfusion pads | Experimental | Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses Receives: Other: Warmed perfusion pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rewarming
Track to rate of rewarming of each arm
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
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 HypothermiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant S Lipman, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339103
- Sponsor's protocol ID
- 31036
- Acronym
- SHIVER
- Status last verified
- Nov 2018
- First submitted
- 12 Jan 2015
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Christensen ML, Lipman GS, Grahn DA, Shea KM, Einhorn J, Heller HC. A Novel Cooling Method and Comparison of Active Rewarming of Mildly Hypothermic Subjects. Wilderness Environ Med. 2017 Jun;28(2):108-115. doi: 10.1016/j.wem.2017.02.009. Epub 2017 May 12.
PubMed 28506514
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)
- ClinicalTrials.gov ID
- NCT02339103
- Acronym / sponsor ID
- SHIVER / 31036
- Conditions
- Hypothermia
- Keywords
- arteriovenous anastomoses, accidental hypothermia, rewarming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jan 2015 (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 compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shivering only | No intervention | –Pt placed in sleeping bag and warmed by shivering only |
| Warmed IV fluids | Experimental | Other: Warmed IV fluids2 Liter of 42 degree celsius normal saline |
| Warmed perfusion pads | Experimental | Other: Warmed perfusion padsWarmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any healthy male or female over 18 years of age
Key exclusion criteria (2 listed)
- No heart/blood pressure/cholesterol medications.
- No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion
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 |
|---|---|---|
| Warmed IV fluids1 Liter of warmed IV fluids at 42 degrees celsius | Other | Warmed IV fluids |
| Warmed perfusion padsNeoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses | Other | Warmed perfusion pads |
Primary outcome
Rate of rewarming
Time frame: 60 minutes
Track to rate of rewarming of each arm
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 26 Nov 2018.
- Results publication: PubMed 28506514Christensen ML, Lipman GS, Grahn DA, Shea KM, Einhorn J, Heller HC. A Novel Cooling Method and Comparison of Active Rewarming of Mildly Hypothermic Subjects. Wilderness Environ Med. 2017 Jun;28(2):108-115. doi: 10.1016/j.wem.2017.02.009. Epub 2017 May 12.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Warmed IV fluids and Warmed perfusion pads in people with Hypothermia, run by Stanford University.
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 2 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of rewarming (time frame: 60 minutes). 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 NCT02339103, 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 26 Nov 2018.