SHIVER: Study of Heat and Intravenous Fluids for Exogenous Rewarming

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT02339103

Collaborator

(none)

Enrollment

Arms

5.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Other: Warmed IV fluids Other: Warmed perfusion pads	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Shivering only Pt placed in sleeping bag and warmed by shivering only
Experimental: Warmed IV fluids 2 Liter of 42 degree celsius normal saline	Other: Warmed IV fluids 1 Liter of warmed IV fluids at 42 degrees celsius
Experimental: Warmed perfusion pads Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses	Other: Warmed perfusion pads Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses

Arm

Intervention/Treatment

No Intervention: Shivering only

Pt placed in sleeping bag and warmed by shivering only

Experimental: Warmed IV fluids

2 Liter of 42 degree celsius normal saline

Other: Warmed IV fluids

1 Liter of warmed IV fluids at 42 degrees celsius

Experimental: Warmed perfusion pads

Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses

Other: Warmed perfusion pads

Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses

Outcome Measures

Primary Outcome Measures

Rate of rewarming [60 minutes]
Track to rate of rewarming of each arm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grant S Lipman, Principle Investigator, Stanford University

ClinicalTrials.gov Identifier:

NCT02339103

Other Study ID Numbers:

31036

First Posted:

Jan 15, 2015

Last Update Posted:

Nov 26, 2018

Last Verified:

Nov 1, 2018

Keywords provided by Grant S Lipman, Principle Investigator, Stanford University

arteriovenous anastomoses

accidental hypothermia

rewarming

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of Nov 26, 2018