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

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Warmed IV fluids
Warmed perfusion pads
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring arteriovenous anastomoses, accidental hypothermia, rewarming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Shivering only

    Warmed IV fluids

    Warmed perfusion pads

    Arm Description

    Pt placed in sleeping bag and warmed by shivering only

    2 Liter of 42 degree celsius normal saline

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

    Outcomes

    Primary Outcome Measures

    Rate of rewarming
    Track to rate of rewarming of each arm

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2015
    Last Updated
    November 21, 2018
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02339103
    Brief Title
    Study of Heat and Intravenous Fluids for Exogenous Rewarming
    Acronym
    SHIVER
    Official Title
    Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia
    Keywords
    arteriovenous anastomoses, accidental hypothermia, rewarming

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Shivering only
    Arm Type
    No Intervention
    Arm Description
    Pt placed in sleeping bag and warmed by shivering only
    Arm Title
    Warmed IV fluids
    Arm Type
    Experimental
    Arm Description
    2 Liter of 42 degree celsius normal saline
    Arm Title
    Warmed perfusion pads
    Arm Type
    Experimental
    Arm Description
    Warmed perfusion pads placed to palms and soles to rewarm through arteriovenous anastomoses
    Intervention Type
    Other
    Intervention Name(s)
    Warmed IV fluids
    Intervention Description
    1 Liter of warmed IV fluids at 42 degrees celsius
    Intervention Type
    Other
    Intervention Name(s)
    Warmed perfusion pads
    Intervention Description
    Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses
    Primary Outcome Measure Information:
    Title
    Rate of rewarming
    Description
    Track to rate of rewarming of each arm
    Time Frame
    60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28506514
    Citation
    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. Erratum In: Wilderness Environ Med. 2017 Dec;28(4):389.
    Results Reference
    result

    Learn more about this trial

    Study of Heat and Intravenous Fluids for Exogenous Rewarming

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