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

October 1, 2015 updated by: Central Hospital, Nancy, France

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Athanase Benetos
      • Nancy, France, 54000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during 3 days: day 0, day 1, day 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
during 3 days: at day 0, day 1, day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Athanase Benetos, Pr, CHU Brabois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 28, 2014

First Posted (ESTIMATE)

July 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00695-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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