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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-06-30

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).

Conditions

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Orthostatic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Hydration

Intervention Type OTHER

Hydratation the first day in the arm 1 Hydration the second day in the arm 2

Venous contention

Intervention Type OTHER

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).

Group Type ACTIVE_COMPARATOR

Hydration

Intervention Type OTHER

Hydratation the first day in the arm 1 Hydration the second day in the arm 2

Venous contention

Intervention Type OTHER

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

Intervention Type OTHER

Venous contention

Venous contention the second day in the arm 1 Venous contention the first day in the arm 2

Intervention Type OTHER

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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Maison Hospitalière Saint Charles

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Athanase Benetos, Pr

Role: CONTACT

0383153322

Marion Serot Gresser

Role: CONTACT

0664524831

Facility Contacts

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Athanase Benetos, Pr

Role: primary

0383153322

Marion Serot Gresser

Role: backup

0664524831

NOEL-RUEF Marie-Hélène

Role: primary

03.83.17.58.07

GRESSER Marion

Role: backup

06.64.52.48.31

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.

Reference Type BACKGROUND
PMID: 18583904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23469486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19214345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1592445 (View on PubMed)

Other Identifiers

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2014-A00695-42

Identifier Type: -

Identifier Source: org_study_id

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