Water and the Gastropressor Response - Tachyphylaxis - Tabular View

Tracking Information

First Received Date ^ICMJE

December 22, 2007

Last Updated Date

June 23, 2009

Start Date ^ICMJE

July 2006

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00580996 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Water and the Gastropressor Response - Tachyphylaxis

Official Title ^ICMJE

Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2)

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Orthostatic Hypotension

Intervention ^ICMJE

Other: water high dose
Other: water tiny dose

Study Arms / Comparison Groups

Experimental: 16 oz water in AM
Active Comparator: water 1 oz in AM

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

pregnancy

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bonnie K Black, RN CNP

adcresearch@vanderbilt.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580996

Responsible Party

Satish R Raj MD MSCI, Vanderbilt University

Study ID Numbers ^ICMJE

060547, Vanderbilt Discovery

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Satish R Raj, MD MSCI

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP