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

November 21, 2018 updated by: Grant S Lipman, Stanford University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of rewarming
Time Frame: 60 minutes
Track to rate of rewarming of each arm
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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