Water and the Gastropressor Response - Diurnal Variability

This study is currently recruiting participants.

Verified by Vanderbilt University, December 2008

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00581373

Purpose

We will test the null hypothesis that there is no diurnal (morning to afternoon)variability in the blood pressure response to the ingestion of water 16 oz.

Condition	Intervention
Orthostatic Hypotension	Other: water 16 fl oz

MedlinePlus related topics: Drinking Water Low Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Water and the Gastropressor Response - Diurnal Variability (Specific Aim 1.3)

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

blood pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental water 16 oz	Other: water 16 fl oz water 16 fl oz in AM and repeat in late afternoon

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

orthostatic intolerance

Exclusion Criteria:

pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581373

Contacts

Contact: Bonnie K Black, RN CNP

adcresearch@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Sub-Investigator: David Robertson, MD
Sub-Investigator: Italo Biaggioni, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Satish R Raj, MD MSCI

Vanderbilt University

More Information

Vanderbilt University Autonomic Dysfunction Center This link exits the ClinicalTrials.gov site

Responsible Party:	Vanderbilt University ( Satish R Raj MD MSCI )
Study ID Numbers:	060553, Vanderbilt Discovery
Study First Received:	December 22, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00581373
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

water
orthostatic hypotension
blood pressure

Study placed in the following topic categories:

Hypotension
Postural hypotension
Hypotension, Orthostatic
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009