Back to resultsWater and the Gastropressor Response - Tachyphylaxis
Primary Purpose
Orthostatic Hypotension
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
water high dose
water tiny dose
Sponsored by
About this trial
This is an interventional other trial for Orthostatic Hypotension focused on measuring water, orthostatic hypotension, blood pressure
Eligibility 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
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
16 oz water in AM
water 1 oz in AM
Outcomes
Primary Outcome Measures
blood pressure
Secondary Outcome Measures
heart rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00580996
Brief Title
Water and the Gastropressor Response - Tachyphylaxis
Official Title
Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Satish R. Raj
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
water, orthostatic hypotension, blood pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
16 oz water in AM
Arm Title
2
Arm Type
Active Comparator
Arm Description
water 1 oz in AM
Intervention Type
Other
Intervention Name(s)
water high dose
Intervention Description
water 16 oz PO x 1
Intervention Type
Other
Intervention Name(s)
water tiny dose
Intervention Description
water 1 oz PO x 1
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
2nd water intervention
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
2nd intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction
Description
Vanderbilt Autonomic Dysfunction Center website
Learn more about this trial
Water and the Gastropressor Response - Tachyphylaxis
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