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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 Medical Center
ClinicalTrials.gov Identifier:
NCT00580996
First received: December 22, 2007
Last updated: March 22, 2017
Last verified: March 2017
  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
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 2nd water intervention ]

Secondary Outcome Measures:
  • heart rate [ Time Frame: 2nd intervention ]

Estimated Enrollment: 20
Study Start Date: July 2006
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00580996     History of Changes
Other Study ID Numbers: 060547
Vanderbilt Discovery
Study First Received: December 22, 2007
Last Updated: March 22, 2017

Keywords provided by Vanderbilt University Medical Center:
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 24, 2017