Hip FracturesPhase 3FRACTALENCT00444262
Stroke Volume Optimisation in Patients With Hip Fracture
A Phase 3 study testing hemodynamic optimisation guided using esophageal Doppler and VOLUVEN and others solute in people with Hip Fractures, run by Assistance Publique - Hôpitaux de Paris at 19 sites in France.
Trial summary
The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- hemodynamic optimisation guided using esophageal Doppler and VOLUVEN and others solute
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 19 sitesFrance
- Study dates
- Apr 2007to Mar 2011
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly subjects (≥ 70 year old) with hip fracture
Who cannot join
- Patient or legal representative unwilling to give informed consent
- Patient with other trauma lesions associated to hip fracture
- Patient with esophageal disease or chronic dissection of the descending aorta (contra-indications to esophageal Doppler monitoring)
- Patient with known active neoplasia or with obvious metastatic hip fracture
- Allergy to hydroxy-ethyl starches
- Congenital hemostatic disorder
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Hopital Avicenne
Bobigny, Seine Saint Denis, 93009
Centre Hospitalier Universitaire de La Cote de Nacre
Caen, Calvados, 14000
Hopital Antoine Beclere
Clamart, Hauts de Seine, 92140
Hopital D'Instruction Des Armees Percy
Clamart, Hauts de Seine, 92140
Hopital Beaujon
Clichy, Hauts de Seine, 92110
Hopital Henri Mondor
Créteil, Val de Marne, 94000
Hopital Bicetre
Le Kremlin-Bicêtre, Val de Marne, 94275
Centre Hospitalier de Meaux
Meaux, Seine Et Marne, 77100
Hopital Lapeyronie
Montpellier, Herault, 34000
Hopital Lariboisiere
Paris, Paris, 75010
Hopital Saint Antoine
Paris, Paris, 75012
Hopital La Pitie Salpetriere
Paris, Paris, 75013
Fondation Saint Joseph
Paris, Paris, 75014
Hopital Cochin
Paris, Paris, 75014
Hopital Europeen Georges Pompidou
Paris, Paris, 75015
Hopital Bichat
Paris, Paris, 75018
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86000
Centre Hospitalier Universitaire Rouen
Rouen, Seine Maritime, 76000
Hopital Purpan
Toulouse, Haute Garonne, 31000
About this study
Official title: Study Multicentric, Randomised, in Duplicate Blind Person of the Impact of a Per Operatory Strategy of Optimization of the Cardiac Output on the Forecast of the Old Subjects Operated for Fracture of the Upper End of the Femur " FRACTALE "
The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.
Read the detailed description
Rationale : Hip fracture patients frequently develop postoperative complications that increase their hospital length of stay and the cost of care. These complications are also associated with increased mortality. Perioperative tissue hypoperfusion may participate in the development of postoperative complications. Hypovolemia is secondary to many factors in hip fracture patients (including blood loss, fasting and dehydration) and can result in low cardiac output and tissue hypoperfusion. Two single-center, randomized, double-blind studies have demonstrated that peroperative fluid titration guided by esophageal Doppler measurements of stroke volume could improve patient outcome. Interpretation of these results was that such a stroke volume "optimisation" strategy could help the anesthesiologist give more fluids to his patient and reduce the risk of hypoperfusion without the risk of congestion, thereby reducing postoperative complications and improving patient outcome. We want to test the same hypothesis in a multicenter trial to confirm with a high level of proof the usefulness of this strategy. If previous results are confirmed, this could lead to a change in current anesthetic management of hip fracture patients and potentially have a very important economical impact on health costs.Goals : Primary endpoint is to demonstrate that colloid (Voluven®) titration, guided using esophageal Doppler estimation of stroke volume, during the surgical repair of hip fracture reduces the incidence of postoperative complications (composite criteria). Secondary endpoints in the "optimised group" include : 1) reduced delay to walk without help ; 2) increased number of days " out-of-hospital " at 3 months after the fracture ; and 3) reduced 1-year mortality.
- Conditions
- Hip Fractures
- Being tested
- hemodynamic optimisation guided using esophageal Doppler, VOLUVEN and others solute
- Keywords
- Hemodynamic optimisation, Esophageal Doppler, Hydroxy ethyl starch, Hip fracture, Outcome, Elderly subjects (≥ 70 year old), General anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamic optimisation guided using esophageal DopplerProcedure or surgery
hemodynamic optimisation guided using esophageal Doppler
VOLUVEN and others soluteDrug
VOLUVEN and others solute
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | conventional treatment Receives: Drug: VOLUVEN and others solute |
| 2 | Experimental | stroke volume optimisation Receives: Procedure: hemodynamic optimisation guided using esophageal Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
We expect a 30% reduction in the number of per- and post-operative complications observed during hospitalisation in acute care beds in the "optimised" subgroup with respect to "conventional" subgroup. Complications include: death, per-operative
Measured: during hospitalisation in acute care
Secondary outcomes (1)
We will check if patients in the "optimised" group have:1) a reduction in the delay to walk without help2) more days " out-of-hospital " at 3 months 3) a reduction in 1-year mortality rate
Measured: at 3 months and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2010
- Study completionMar 2011
Why it stopped: termination of the study due to difficulties to include patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi, GAMIDA
- Responsible party
- Sponsor
- Investigators
- bernard CHOLLEY, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444262
- Sponsor's protocol ID
- P051009-AOM 05086
- Acronym
- FRACTALE
- Status last verified
- Jun 2011
- First submitted
- 6 Mar 2007
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Multicentric, Randomised, in Duplicate Blind Person of the Impact of a Per Operatory Strategy of Optimization of the Cardiac Output on the Forecast of the Old Subjects Operated for Fracture of the Upper End of the Femur " FRACTALE "
- ClinicalTrials.gov ID
- NCT00444262
- Acronym / sponsor ID
- FRACTALE / P051009-AOM 05086
- Conditions
- Hip Fractures
- Keywords
- Hemodynamic optimisation, Esophageal Doppler, Hydroxy ethyl starch, Hip fracture, Outcome, Elderly subjects (≥ 70 year old), General anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: termination of the study due to difficulties to include patients
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fresenius Kabi, GAMIDA
- Study start
- Apr 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Mar 2007 (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.
The aim of this study is to assess whether intra-operative fluid supplementation (to improve tissue perfusion) can reduce the incidence of postoperative complications in elderly patients with hip fracture.
Detailed description
Rationale : Hip fracture patients frequently develop postoperative complications that increase their hospital length of stay and the cost of care. These complications are also associated with increased mortality. Perioperative tissue hypoperfusion may participate in the development of postoperative complications. Hypovolemia is secondary to many factors in hip fracture patients (including blood loss, fasting and dehydration) and can result in low cardiac output and tissue hypoperfusion. Two single-center, randomized, double-blind studies have demonstrated that peroperative fluid titration guided by esophageal Doppler measurements of stroke volume could improve patient outcome. Interpretation of these results was that such a stroke volume "optimisation" strategy could help the anesthesiologist give more fluids to his patient and reduce the risk of hypoperfusion without the risk of congestion, thereby reducing postoperative complications and improving patient outcome. We want to test the same hypothesis in a multicenter trial to confirm with a high level of proof the usefulness of this strategy. If previous results are confirmed, this could lead to a change in current anesthetic management of hip fracture patients and potentially have a very important economical impact on health costs.Goals : Primary endpoint is to demonstrate that colloid (Voluven®) titration, guided using esophageal Doppler estimation of stroke volume, during the surgical repair of hip fracture reduces the incidence of postoperative complications (composite criteria). Secondary endpoints in the "optimised group" include : 1) reduced delay to walk without help ; 2) increased number of days " out-of-hospital " at 3 months after the fracture ; and 3) reduced 1-year mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: VOLUVEN and others soluteconventional treatment |
| 2 | Experimental | Procedure: hemodynamic optimisation guided using esophageal Dopplerstroke volume optimisation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly subjects (≥ 70 year old) with hip fracture
Key exclusion criteria (6 listed)
- Patient or legal representative unwilling to give informed consent
- Patient with other trauma lesions associated to hip fracture
- Patient with esophageal disease or chronic dissection of the descending aorta (contra-indications to esophageal Doppler monitoring)
- Patient with known active neoplasia or with obvious metastatic hip fracture
- Allergy to hydroxy-ethyl starches
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 |
|---|---|---|
| hemodynamic optimisation guided using esophageal Dopplerhemodynamic optimisation guided using esophageal Doppler | Procedure or surgery | 2 |
| VOLUVEN and others soluteVOLUVEN and others solute | Drug | 1 |
Primary outcome
We expect a 30% reduction in the number of per- and post-operative complications observed during hospitalisation in acute care beds in the "optimised" subgroup with respect to "conventional" subgroup. Complications include: death, per-operative
Time frame: during hospitalisation in acute care
1 secondary outcome
We will check if patients in the "optimised" group have:1) a reduction in the delay to walk without help2) more days " out-of-hospital " at 3 months 3) a reduction in 1-year mortality rate
Time frame: at 3 months and at one year
Results and safety
The study was stopped early (reason given: termination of the study due to difficulties to include patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
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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.
bernard CHOLLEY, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hemodynamic optimisation guided using esophageal Doppler and VOLUVEN and others solute in people with Hip Fractures, run by Assistance Publique - Hôpitaux de Paris at 19 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: termination of the study due to difficulties to include patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We expect a 30% reduction in the number of per- and post-operative complications observed during hospitalisation in acute care beds in the "optimised" subgroup with respect to "conventional" subgroup. Complications include: death, per-operative (time frame: during hospitalisation in acute care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2011.