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NCT02339103 Clinical Trial

Study of Heat and Intravenous Fluids for Exogenous Rewarming

Hypothermia Clinical Trial

— SHIVER  

Official title:
Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02339103
Other study ID # 31036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date July 2015

Study information
Verified date November 2018
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Any healthy male or female over 18 years of age

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Warmed IV fluids
1 Liter of warmed IV fluids at 42 degrees celsius
• Warmed perfusion pads
Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of rewarming Track to rate of rewarming of each arm 60 minutes
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