Stroke Volume Optimisation in Patients With Hip Fracture (FRACTALE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Fractures |
Procedure: hemodynamic optimisation guided using esophageal Doppler Drug: VOLUVEN and others solute |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 " |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 215 |
| Study Start Date: | April 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
conventional treatment
|
Drug: VOLUVEN and others solute
VOLUVEN and others solute
Other Name: VOLUVEN and others solute
|
|
Experimental: 2
stroke volume optimisation
|
Procedure: hemodynamic optimisation guided using esophageal Doppler
hemodynamic optimisation guided using esophageal Doppler
Other Name: hemodynamic optimisation guided using esophageal Doppler
|
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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Elderly subjects (≥ 70 year old) with hip fracture
Exclusion criteria:
- 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
Contacts and Locations| France | |
| Centre Hospitalier Universitaire de La Cote de Nacre | |
| Caen, Calvados, France, 14000 | |
| Hopital Purpan | |
| Toulouse, Haute Garonne, France, 31000 | |
| Hopital Antoine Beclere | |
| Clamart, Hauts de Seine, France, 92140 | |
| Hopital D'Instruction Des Armees Percy | |
| Clamart, Hauts de Seine, France, 92140 | |
| Hopital Beaujon | |
| Clichy, Hauts de Seine, France, 92110 | |
| Hopital Lapeyronie | |
| Montpellier, Herault, France, 34000 | |
| Centre Hospitalier de Meaux | |
| Meaux, Seine Et Marne, France, 77100 | |
| Centre Hospitalier Universitaire Rouen | |
| Rouen, Seine Maritime, France, 76000 | |
| Hopital Avicenne | |
| Bobigny, Seine Saint Denis, France, 93009 | |
| Hopital Henri Mondor | |
| Creteil, Val de Marne, France, 94000 | |
| Hopital Bicetre | |
| Le Kremlin Bicetre, Val de Marne, France, 94275 | |
| Centre Hospitalier Universitaire de Poitiers | |
| Poitiers, Vienne, France, 86000 | |
| Fondation Saint Joseph | |
| Paris, France, 75014 | |
| Hopital Saint Antoine | |
| Paris, France, 75012 | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Hopital Lariboisiere | |
| Paris, France, 75010 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Bichat | |
| Paris, France, 75018 | |
| Hopital La Pitie Salpetriere | |
| Paris, France, 75013 | |
| Principal Investigator: | bernard CHOLLEY, MD PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00444262 History of Changes |
| Other Study ID Numbers: | P051009-AOM 05086 |
| Study First Received: | March 6, 2007 |
| Last Updated: | October 6, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Hemodynamic optimisation Esophageal Doppler Hydroxy ethyl starch Hip fracture |
Outcome Elderly subjects (≥ 70 year old) General anesthesia |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Wounds and Injuries Femoral Fractures Hip Injuries Leg Injuries |
Hetastarch Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013