Water and the Gastropressor Response - Tachyphylaxis - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00580996

Purpose

We are studying the effects of oral water ingestion in patients with orthostatic hypotension. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier.

Condition	Intervention
Orthostatic Hypotension	Other: water high dose Other: water tiny dose

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2)

Resource links provided by NLM:

MedlinePlus related topics: Low Blood Pressure

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

blood pressure [ Time Frame: 2nd water intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

heart rate [ Time Frame: 2nd intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 16 oz water in AM	Other: water high dose water 16 oz PO x 1
Active Comparator: 2 water 1 oz in AM	Other: water tiny dose water 1 oz PO x 1

Detailed Description:

We are studying the effects of oral water ingestion in patients with orthostatic hypotension. This has been termed the Gastropressor Response. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier. In this 2 day study, subjects will be asked to drink with 1 oz or 16 oz of water in the morning followed a few hours later by 16 oz water while the blood pressure is monitored. On the 2nd day, the other dose of water will be given to start, with 16 oz again as the second dose.

Eligibility

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

Criteria

Inclusion Criteria:

orthostatic hypotension (fall in BP>20/10 mmHg)
pressor response to water in other studies
Age 18-80 years

Exclusion Criteria:

pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580996

Contacts

Contact: Bonnie K Black, RN CNP

adcresearch@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: David Robertson, MD
Sub-Investigator: Italo Biaggioni, MD
Sub-Investigator: Bonnie K Black, NP

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Satish R Raj, MD MSCI

Vanderbilt University

More Information

Additional Information:

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

No publications provided

Responsible Party:	Satish R Raj MD MSCI, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00580996 History of Changes
Other Study ID Numbers:	060547, Vanderbilt Discovery
Study First Received:	December 22, 2007
Last Updated:	June 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

water
orthostatic hypotension
blood pressure

Additional relevant MeSH terms:

Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases

Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012