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| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2007 | ||||
| Last Updated Date | June 23, 2009 | ||||
| Start Date ICMJE | July 2006 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
blood pressure [ Time Frame: 2nd water intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00580996 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
heart rate [ Time Frame: 2nd intervention ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Water and the Gastropressor Response - Tachyphylaxis | ||||
| Official Title ICMJE | Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2) | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE | Orthostatic Hypotension | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00580996 | ||||
| Responsible Party | Satish R Raj MD MSCI, Vanderbilt University | ||||
| Study ID Numbers ICMJE | 060547, Vanderbilt Discovery | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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