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Heat Stress and Volume Administration

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00714766
First received: July 10, 2008
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention
Syncope
 Procedure: Intravascular volume administration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Heat Stress and Volume Administration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Cardiac filling pressure in relation to cardiac SV [ Time Frame: with varying degress of lower body negative pressures ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Procedure: Intravascular volume administration
Infusion of colloid to reestablish CVP under heat stress

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 < 40

Exclusion Criteria:

  • Abnormal medical history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714766

Locations
Denmark
Dept of anesthesiology 2041
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Niels Secher, MD, PhD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Niels Secher, Professor, Righospitale
ClinicalTrials.gov Identifier: NCT00714766     History of Changes
Other Study ID Numbers: Heat stress RH08
Study First Received: July 10, 2008
Last Updated: February 13, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Syncope
Heat Stress Disorders
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013