CClinicalTrials.gg
Status unknownNCT02179216CHHOUpdated Oct 2, 2015

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

An interventional study of Hydration and Venous contention in Orthostatic Hypotension, sponsored by Central Hospital, Nancy, France. Status unknown at 2 sites in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study 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

Read the 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).
02

Conditions studied

  • Orthostatic Hypotension

Keywords

  • Orthostatic hypotension in the elderly
  • Efficacity of Hydration
  • Difference between hydratation and venous contention
03

In context

Hypotension, Orthostatic

155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.

This study's planned enrollment of 110 is above the median of 30 across 113 interventional studies indexed under Hypotension, Orthostatic.

Browse Hypotension, Orthostatic studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • 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 · Other: Venous contention

  • 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 · Other: Venous contention

Interventions

  • OtherHydration

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

  • OtherVenous contention

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

06

What researchers measure

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

    Time frame: 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

    Time frame: during 3 days: at day 0, day 1, day 2

07

Study locations

2 of 2 sites recruiting
  • Centre Hospitalier Régional Universitaire de Nancy
    Nancy, 54000, France
    Recruiting
  • Maison Hospitalière Saint Charles
    Nancy, 54000, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 18583904 ↗
  • 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. PubMed 23469486 ↗
  • 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. PubMed 19214345 ↗
  • 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. PubMed 1592445 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02179216
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Jul 1, 2014
Start date
Jul 2014
Primary completion
May 2016 (estimated)
Completion
Jun 2016 (estimated)
Last update
Oct 2, 2015

Study contacts

Athanase Benetos, Pr
Contact
a.benetos@chu-nancy.fr
0383153322
Marion Serot Gresser
Contact
mariongresser@hotmail.fr
0664524831
Athanase Benetos, Pr
principal investigator · CHU Brabois

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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