Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression
CHHO
1 other identifier
interventional
110
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 2, 2015
October 1, 2015
1.8 years
June 24, 2014
October 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (2)
Hydration
ACTIVE COMPARATOR•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.
Venous contention
ACTIVE COMPARATOR•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).
Interventions
Hydratation the first day in the arm 1 Hydration the second day in the arm 2
Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Hospitalier Régional Universitaire de Nancy
Nancy, 54000, France
Maison Hospitalière Saint Charles
Nancy, 54000, France
Related 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.
PMID: 18583904BACKGROUNDTyberghein M, Philips JC, Krzesinski JM, Scheen AJ. [Orthostatic hypotension: definition, symptoms, assessment and pathophysiology]. Rev Med Liege. 2013 Feb;68(2):65-73. French.
PMID: 23469486BACKGROUNDSchols 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.
PMID: 19214345BACKGROUNDRutan 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.
PMID: 1592445BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athanase Benetos, Pr
CHU Brabois
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2014
First Posted
July 1, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
October 2, 2015
Record last verified: 2015-10