Overview

This trial is active, not recruiting.

Condition orthostatic hypotension
Treatments water high dose, water tiny dose
Sponsor Satish R. Raj
Start date July 2006
End date December 2014
Trial size 20 participants
Trial identifier NCT00580996, 060547, Vanderbilt Discovery

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
16 oz water in AM
water high dose
water 16 oz PO x 1
(Active Comparator)
water 1 oz in AM
water tiny dose
water 1 oz PO x 1

Primary Outcomes

Measure
blood pressure
time frame: 2nd water intervention

Secondary Outcomes

Measure
heart rate
time frame: 2nd intervention

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2)
Principal investigator Satish R Raj, MD MSCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Vanderbilt University.