Clinical Trial: Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.
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 Summary:
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).
Sponsor: Central Hospital, Nancy, France
Current Primary Outcome: 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 ]
Original Primary Outcome: difference in systolic blood pressure between sitting and standing at 1 and 3 minutes after hydration [ Time Frame: during 3 days: at day 0, day 1, day 2 ]
Current Secondary Outcome: difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between hypotension test with hydration and hypotension test without prevention [ Time Frame: during 3 days: at day 0, day 1, day 2 ]
Original Secondary Outcome: difference in systolic blood pressure between sitting and standing at 1 and 3 minutes between prevention hydration and preventing venous contention [ Time Frame: during 3 days: day 0, day 1, day 2 ]
Information By: Central Hospital, Nancy, France
Dates:
Date Received: June 24, 2014
Date Started: July 2014
Date Completion: June 2016
Last Updated: October 1, 2015
Last Verified: October 2015
