Water and the Gastropressor Response - Tachyphylaxis

Sponsor

Satish R. Raj (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00580996

Collaborator

(none)

Enrollment

Location

Arms

233

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension	Other: water high dose Other: water tiny dose	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jul 1, 2006

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

blood pressure [2nd water intervention]

Secondary Outcome Measures

heart rate [2nd intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Satish R. Raj

Investigators

Principal Investigator: Satish R Raj, MD MSCI, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT00580996

Other Study ID Numbers:

060547
Vanderbilt Discovery

First Posted:

Dec 27, 2007

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Keywords provided by Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University Medical Center

water

orthostatic hypotension

blood pressure

Additional relevant MeSH terms:

Hypotension, Orthostatic

Hypotension

Study Results

No Results Posted as of Sep 8, 2021