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

Orthostatic Hypotension Clinical Trial

— CHHO  

Official title:

Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02179216
• Other study ID #: 2014-A00695-42
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2014
• Last updated: October 1, 2015
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Central Hospital, Nancy, France
• Contact: Athanase Benetos, Pr
• Phone: 0383153322
• Email: a.benetos[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy	Nancy
France	Maison Hospitalière Saint Charles	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		during 3 days: day 0, day 1, day 2	Yes
Secondary	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	Yes