Orthostatic HypotensionCHHONCT02179216
Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression
A study testing Hydration and Venous contention in people with Orthostatic Hypotension, run by Central Hospital, Nancy, France at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Hydration and Venous contention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy
Nancy, 54000
Athanase Benetos, Pr, 0383153322, a.benetos@chu-nancy.fr
Marion Serot Gresser, 0664524831, mariongresser@hotmail.fr
- Recruiting
Maison Hospitalière Saint Charles
Nancy, 54000
NOEL-RUEF Marie-Hélène, 03.83.17.58.07, mh.noel@saint-charles.fr
GRESSER Marion, 06.64.52.48.31, mariongresser@hotmail.fr
About this study
Official title: 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
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).
- Conditions
- Orthostatic Hypotension
- Being tested
- Hydration, Venous contention
- Keywords
- Orthostatic hypotension in the elderly, Efficacity of Hydration, Difference between hydratation and venous contention
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrationOther
Hydratation the first day in the arm 1 Hydration the second day in the arm 2
Venous contentionOther
Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hydration; Other: Venous contention |
| 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). Receives: Other: Hydration; Other: Venous contention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: during 3 days: at day 0, day 1, day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athanase Benetos, Pr, Principal investigator, CHU Brabois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179216
- Sponsor's protocol ID
- 2014-A00695-42
- Acronym
- CHHO
- Status last verified
- Oct 2015
- First submitted
- 24 Jun 2014
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 18583904Tyberghein 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 23469486Schols 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 19214345Rutan 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.
- ClinicalTrials.gov ID
- NCT02179216
- Acronym / sponsor ID
- CHHO / 2014-A00695-42
- Conditions
- Orthostatic Hypotension
- Keywords
- Orthostatic hypotension in the elderly, Efficacity of Hydration, Difference between hydratation and venous contention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydration | Active comparator | Other: Hydration, Other: Venous contention•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 | Other: Hydration, Other: 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). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrationHydratation the first day in the arm 1 Hydration the second day in the arm 2 | Other | Hydration, Venous contention |
| Venous contentionVenous contention the second day in the arm 1 Venous contention the first day in the arm 2 | Other | Hydration, Venous contention |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Background: PubMed 18583904Gorelik 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.
- Background: PubMed 23469486Tyberghein M, Philips JC, Krzesinski JM, Scheen AJ. [Orthostatic hypotension: definition, symptoms, assessment and pathophysiology]. Rev Med Liege. 2013 Feb;68(2):65-73. French.
- Background: PubMed 19214345Schols 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.
- Background: PubMed 1592445Rutan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanase Benetos, Pr principal investigator
CHU Brabois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration and Venous contention in people with Orthostatic Hypotension, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athanase Benetos, Pr (0383153322, a.benetos@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179216, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.