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

Primary Purpose

Orthostatic Hypotension

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hydration
Venous contention
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthostatic Hypotension focused on measuring Orthostatic hypotension in the elderly, Efficacity of Hydration, Difference between hydratation and venous contention

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Régional Universitaire de NancyRecruiting
  • Maison Hospitalière Saint CharlesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hydration

Venous contention

Arm Description

•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 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).

Outcomes

Primary Outcome 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

Secondary Outcome 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

Full Information

First Posted
June 24, 2014
Last Updated
October 1, 2015
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02179216
Brief Title
Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression
Acronym
CHHO
Official Title
Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
Orthostatic hypotension in the elderly, Efficacity of Hydration, Difference between hydratation and venous contention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydration
Arm Type
Active Comparator
Arm Description
•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.
Arm Title
Venous contention
Arm Type
Active Comparator
Arm Description
•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).
Intervention Type
Other
Intervention Name(s)
Hydration
Intervention Description
Hydratation the first day in the arm 1 Hydration the second day in the arm 2
Intervention Type
Other
Intervention Name(s)
Venous contention
Intervention Description
Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athanase Benetos, Pr
Phone
0383153322
Email
a.benetos@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Serot Gresser
Phone
0664524831
Email
mariongresser@hotmail.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanase Benetos, Pr
Organizational Affiliation
CHU Brabois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanase Benetos, Pr
Phone
0383153322
Email
a.benetos@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Marion Serot Gresser
Phone
0664524831
Email
mariongresser@hotmail.fr
First Name & Middle Initial & Last Name & Degree
Athanase Benetos
Facility Name
Maison Hospitalière Saint Charles
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NOEL-RUEF Marie-Hélène
Phone
03.83.17.58.07
Email
mh.noel@saint-charles.fr
First Name & Middle Initial & Last Name & Degree
GRESSER Marion
Phone
06.64.52.48.31
Email
mariongresser@hotmail.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
18583904
Citation
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.
Results Reference
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PubMed Identifier
23469486
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.
Results Reference
background
PubMed Identifier
19214345
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. doi: 10.1007/s12603-009-0023-z.
Results Reference
background
PubMed Identifier
1592445
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. doi: 10.1161/01.hyp.19.6.508.
Results Reference
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Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression

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