Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression
NCT ID: NCT02179216
Last Updated: 2015-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2014-07-31
2016-06-30
Brief Summary
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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
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Hydration
•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.
Hydration
Hydratation the first day in the arm 1 Hydration the second day in the arm 2
Venous contention
Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
Venous contention
•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).
Hydration
Hydratation the first day in the arm 1 Hydration the second day in the arm 2
Venous contention
Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
Interventions
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Hydration
Hydratation the first day in the arm 1 Hydration the second day in the arm 2
Venous contention
Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
Eligibility Criteria
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Inclusion Criteria
* Written consent of the subject
* Hospitalization or stay expected minimum 3 days
* Affiliation to a social security scheme
Exclusion Criteria
* 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
75 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Athanase Benetos, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU Brabois
Locations
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Centre Hospitalier Régional Universitaire de Nancy
Nancy, , France
Maison Hospitalière Saint Charles
Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Gorelik O, Almoznino-Sarafian D, Litvinov V, Alon I, Shteinshnaider M, Dotan E, Modai D, Cohen N. Seating-induced postural hypotension is common in older patients with decompensated heart failure and may be prevented by lower limb compression bandaging. Gerontology. 2009;55(2):138-44. doi: 10.1159/000141920. Epub 2008 Jun 27.
Tyberghein M, Philips JC, Krzesinski JM, Scheen AJ. [Orthostatic hypotension: definition, symptoms, assessment and pathophysiology]. Rev Med Liege. 2013 Feb;68(2):65-73. French.
Schols JM, De Groot CP, van der Cammen TJ, Olde Rikkert MG. Preventing and treating dehydration in the elderly during periods of illness and warm weather. J Nutr Health Aging. 2009 Feb;13(2):150-7. doi: 10.1007/s12603-009-0023-z.
Rutan GH, Hermanson B, Bild DE, Kittner SJ, LaBaw F, Tell GS. Orthostatic hypotension in older adults. The Cardiovascular Health Study. CHS Collaborative Research Group. Hypertension. 1992 Jun;19(6 Pt 1):508-19. doi: 10.1161/01.hyp.19.6.508.
Other Identifiers
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2014-A00695-42
Identifier Type: -
Identifier Source: org_study_id
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