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Water and the Gastropressor Response - Tachyphylaxis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00580996
First received: December 22, 2007
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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:

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 2014
Estimated Primary Completion Date: December 2014 (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

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Satish R. Raj
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, Assistant Professor of Medicine & Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00580996     History of Changes
Other Study ID Numbers: 060547, Vanderbilt Discovery
Study First Received: December 22, 2007
Last Updated: January 7, 2013
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 May 16, 2013