Study of Heat and Intravenous Fluids for Exogenous Rewarming
SHIVER
1 other identifier
interventional
8
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 26, 2018
November 1, 2018
6 months
January 12, 2015
November 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of rewarming
Track to rate of rewarming of each arm
60 minutes
Study Arms (3)
Shivering only
NO INTERVENTIONPt placed in sleeping bag and warmed by shivering only
Warmed IV fluids
EXPERIMENTAL2 Liter of 42 degree celsius normal saline
Warmed perfusion pads
EXPERIMENTALWarmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses
Interventions
Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses
Eligibility Criteria
You may qualify if:
- Any healthy male or female over 18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28506514RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 15, 2015
Study Start
January 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 26, 2018
Record last verified: 2018-11