NCT00714766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

1 month

First QC Date

July 10, 2008

Last Update Submit

February 13, 2009

Conditions

Syncope

Outcome Measures

Primary Outcomes (1)

  • Cardiac filling pressure in relation to cardiac SV

    with varying degress of lower body negative pressures

Study Arms (1)

A

EXPERIMENTAL
Procedure: Intravascular volume administration

Interventions

Intravascular volume administrationPROCEDURE

Infusion of colloid to reestablish CVP under heat stress

A

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 \< 40

You may not qualify if:

  • Abnormal medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of anesthesiology 2041

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Niels Secher, MD, PhD

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 14, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

DK(1)