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

Overview

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

Full Title of Study: “Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

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).

Interventions

  • Other: Hydration
    • Hydratation the first day in the arm 1 Hydration the second day in the arm 2
  • Other: Venous contention
    • Venous contention the second day in the arm 1 Venous contention the first day in the arm 2

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Athanase Benetos, Pr, Principal Investigator, CHU Brabois
  • Overall Contact(s)
    • Athanase Benetos, Pr, 0383153322, a.benetos@chu-nancy.fr

References

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.

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.

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