Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression

Study Overview
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Brief Summary
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Primary objective: To compare the decrease in systolic blood pressure between hydration and venous contention when switching to a standing position. Hypothesis in that hydration is better than venous contention. Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure during the passage standing in elderly patients with orthostatic hypotension. Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1 and / or 3 min

Detailed Description
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Day 0: confirmation of the orthostatic hypotension, without prevented measures Two groups randomized : Group 1: First day (day 1), Orthostatic Hypotension test after hydration by three large glasses of clear liquid (33cl). Second day (day 2), Orthostatic Hypotension test with venous contention in the morning. Group 2: First day (day 1), Orthostatic Hypotension test after implementation of venous contention in the morning. Second day (day 2), Orthostatic Hypotension after hydration by three large glasses of clear liquid (33cl).

Official Title
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Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.

Conditions
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Orthostatic Hypotension

Intervention / Treatment
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* Other: Hydration
* Other: Venous contention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 75 and older with orthostatic hypotension proved to 1 and / or 3 minutes. Written consent of the subject Hospitalization or stay expected minimum 3 days Affiliation to a social security scheme Exclusion Criteria: bedridden patient or without possibility of verticalization Patient who can't stand up (pulmonary embolism with high risk) Patient who refuse to participate in the study Patient with legal protection State or condition that may affect the stability of blood pressure during the study (hyperthermia, modification antihypertensive treatments less than 48 hours before inclusion...) Pathology preventing hydration: Heart failure with less than 1 Liter water restriction, swallowing disorders preventing hydration orally, inability to nutrition and hydration orally Intravenous or subcutaneous hydration (intravenous or subcutaneous treatments not included) Patient who can't have venous contention: Blue phlebitis, septic thrombosis, arteritis with score less than 0.6, varicose ulcers during treatment

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydration<br>•Group 1: First day, Orthostatic Hypotension test after hydration by three large glasses of clear liquid (33cl). Second day, Orthostatic Hypotension test with venous contention in the morning. | Other: Hydration<br>* Hydratation the first day in the arm 1 Hydration the second day in the arm 2<br>Other: Venous contention<br>* Venous contention the second day in the arm 1 Venous contention the first day in the arm 2<br>|
| Active Comparator: Venous contention<br>•Group 2: First day, Orthostatic Hypotension test after implementation of venous contention in the morning. Second day, Orthostatic Hypotension test after hydration by three large glasses of clear liquid (33cl). | Other: Hydration<br>* Hydratation the first day in the arm 1 Hydration the second day in the arm 2<br>Other: Venous contention<br>* Venous contention the second day in the arm 1 Venous contention the first day in the arm 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between hypotension test with hydration and hypotension test with venous contention |  | during 3 days: day 0, day 1, day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between hypotension test with hydration and hypotension test without prevention |  | during 3 days: at day 0, day 1, day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthostatic hypotension in the elderly, Efficacity of Hydration, Difference between hydratation and venous contention