NCT02179216UnknownNot Applicable
Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.
Central Hospital, Nancy, France4 sites in 1 country110 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 110
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Time Frame: during 3 days: day 0, day 1, day 2
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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