Back to resultsHeat Stress and Volume Administration
Primary Purpose
Syncope
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intravascular volume administration
Sponsored by
About this trial
This is an interventional basic science trial for Syncope
Eligibility Criteria
Inclusion Criteria:
- Age > 18 < 40
Exclusion Criteria:
- Abnormal medical history
Sites / Locations
- Dept of anesthesiology 2041
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Cardiac filling pressure in relation to cardiac SV
Secondary Outcome Measures
Full Information
NCT ID
NCT00714766
First Posted
July 10, 2008
Last Updated
February 13, 2009
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00714766
Brief Title
Heat Stress and Volume Administration
Official Title
Heat Stress and Volume Administration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intravascular volume administration
Intervention Description
Infusion of colloid to reestablish CVP under heat stress
Primary Outcome Measure Information:
Title
Cardiac filling pressure in relation to cardiac SV
Time Frame
with varying degress of lower body negative pressures
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 18 < 40
Exclusion Criteria:
Abnormal medical history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Secher, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Dept of anesthesiology 2041
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Heat Stress and Volume Administration
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