Back to resultsWater and the Gastropressor Response - Diurnal Variability
Primary Purpose
Orthostatic Hypotension
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
water 16 fl oz
Sponsored by
About this trial
This is an interventional treatment trial for Orthostatic Hypotension focused on measuring water, orthostatic hypotension, blood pressure
Eligibility Criteria
Inclusion Criteria:
- orthostatic intolerance
Exclusion Criteria:
- pregnancy
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
water 16 oz
Outcomes
Primary Outcome Measures
blood pressure
Secondary Outcome Measures
heart rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00581373
Brief Title
Water and the Gastropressor Response - Diurnal Variability
Official Title
Water and the Gastropressor Response - Diurnal Variability (Specific Aim 1.3)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2007 (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 will test the null hypothesis that there is no diurnal (morning to afternoon)variability in the blood pressure response to the ingestion of water 16 oz.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
water 16 oz
Intervention Type
Other
Intervention Name(s)
water 16 fl oz
Intervention Description
water 16 fl oz in AM and repeat in late afternoon
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
1 day
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
1 day
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 intolerance
Exclusion Criteria:
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
Vanderbilt University
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 University Autonomic Dysfunction Center
Learn more about this trial
Water and the Gastropressor Response - Diurnal Variability
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