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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Fresenius AG GAMIDA |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00444262 |
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 |
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Hip Fractures |
Procedure: hemodynamic optimisation guided using esophageal Doppler Drug: VOLUVEN and others solute |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy 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 " |
Estimated Enrollment: | 800 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
conventional treatment
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Drug: VOLUVEN and others solute
VOLUVEN and others solute
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2: Experimental
stroke volume optimisation
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Procedure: hemodynamic optimisation guided using esophageal Doppler
hemodynamic optimisation guided using esophageal Doppler
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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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: bernard CHOLLEY, MD PhD | 01 49 95 80 84 | bernard.cholley@lrb.aphp.fr |
France | |
Hopital Lariboisiere | Recruiting |
PARIS, France, 75010 | |
Contact: Bernard CHOLLEY, MD PhD +33 1 49 95 80 84 bernard.cholley@lrb.aphp.fr | |
Principal Investigator: BERNARD CHOLLEY, MD PhD | |
Sub-Investigator: DIDIER PAYEN, Professor | |
Hopital Saint Antoine | Not yet recruiting |
PARIS, France, 75012 | |
Contact: MARC PANBOUKDJIAN, MD PhD +33 1 49 28 23 62 markiller33@hotmail.com | |
Principal Investigator: MARC PANBOUKDJIAN, MD PhD | |
Hopital La Pitie Salpetriere | Recruiting |
PARIS, France, 75013 | |
Contact: SABINE ROCHE, MD PhD +33 1 42 17 73 21 sabine.roche@psl.aphp.fr | |
Principal Investigator: SABINE ROCHE, MD PhD | |
Hopital Cochin | Not yet recruiting |
PARIS, France, 75014 | |
Contact: LUC EYROLLE, MD PhD +33 1 58 41 14 19 luc.eyrolle@cch.aphp.fr | |
Principal Investigator: LUC EYROLLE, MD PhD | |
Sub-Investigator: ALEXANDRE MIGNON, MD PhD | |
Hopital Europeen Georges Pompidou | Recruiting |
PARIS, France, 75015 | |
Contact: DIDIER JOURNOIS, MD PhD +33 1 56 09 33 51 didier.journois@egp.aphp.fr | |
Principal Investigator: DIDIER JOURNOIS, MD PhD | |
Sub-Investigator: PHILIPPE CADI, MD PhD | |
Hopital Bichat | Not yet recruiting |
PARIS, France, 75018 | |
Contact: ISABELLE MARTIN, MD PhD +33 1 40 25 83 51 isabelle.martin@bch.aphp.fr | |
Principal Investigator: ISABELLE MARTIN, MD PhD | |
Fondation Saint Joseph | Recruiting |
PARIS, France, 75014 | |
Contact: PATRICIA ROUCHE, MD PhD +33 1 44 12 34 32 patriciarouche@hotmail.com | |
Principal Investigator: PATRICIA ROUCHE, MD PhD | |
France, CALVADOS | |
Centre Hospitalier Universitaire De La Cote De Nacre | Not yet recruiting |
CAEN, CALVADOS, France, 14000 | |
Contact: JEAN LUC HANOUZ, MD PhD +33 2 31 06 47 36 hanouz-jl@chu-caen.fr | |
Principal Investigator: JEAN-LUC HANOUZ, MD PhD | |
France, Haute Garonne | |
Hopital Purpan | Recruiting |
TOULOUSE, Haute Garonne, France, 31000 | |
Contact: MICHEL OLIVIER +33 5 61 77 74 43 olivier.m@chu-toulouse.fr | |
Principal Investigator: MICHEL OLIVIER, MD PhD | |
Sub-Investigator: QUENTIN GOBERT, MD PhD | |
France, Hauts De Seine | |
Hopital Beaujon | Recruiting |
CLICHY, Hauts De Seine, France, 92110 | |
Contact: MARIE MADELEINE AGOSTINI, MD PhD +33 1 40 87 50 00 marie-madeleine.agostini@bjn.aphp.fr | |
Principal Investigator: MARIE-MADELEINE AGOSTINI, MD PhD | |
Hopital Antoine Beclere | Recruiting |
CLAMART, Hauts De Seine, France, 92140 | |
Contact: MARIE BRUYERE, MD PhD +33 1 45 37 42 73 marie.bruyere@abc.aphp.fr | |
Principal Investigator: MARIE BRUYERE, MD PhD | |
Sub-Investigator: CHRISTOPHE HERICHE, MD PhD | |
Hopital D'Instruction Des Armees Percy | Recruiting |
CLAMART, Hauts De Seine, France, 92140 | |
Contact: SYLVAIN AUSSET, MD PhD +33 1 41 46 63 57 lsausset@free.fr | |
Principal Investigator: SYLVAIN AUSSET, MD PhD | |
Sub-Investigator: GUILLAUME DE SAINT MAURICE, MD PhD | |
France, HERAULT | |
Hopital Lapeyronie | Not yet recruiting |
MONTPELLIER, HERAULT, France, 34000 | |
Contact: PHILIPPE BIBOULET, MD PhD +33 4 67 33 82 56 p-biboulet@chu-montpelllier.fr | |
Principal Investigator: PHILIPPE BIBOULET, MD PhD | |
Sub-Investigator: DIDIER MORAU, MD PhD | |
France, Seine Et Marne | |
Centre Hospitalier De Meaux | Recruiting |
MEAUX, Seine Et Marne, France, 77100 | |
Contact: JEAN MARC PUJOL, MD PhD +33 1 64 35 12 73 7766jm.pujol@wanadoo.fr | |
Principal Investigator: JEAN-MARC PUJOL, MD PhD | |
France, Seine Maritime | |
Centre Hospitalier Universitaire Rouen | Recruiting |
ROUEN, Seine Maritime, France, 76000 | |
Contact: MARIE BOREL, MD Ph D +33 2 32 88 64 03 marie.borel@chu-rouen.fr | |
Principal Investigator: MARIE BOREL, MD PhD | |
France, Seine Saint Denis | |
Hopital Avicenne | Recruiting |
BOBIGNY, Seine Saint Denis, France, 93009 | |
Contact: CHRISTOPHE BAILLARD, MD PhD +33 1 48 95 55 91 christophe.baillard@avc.aphp.fr | |
Principal Investigator: CHRISTOPHE BAILLARD, MD PhD | |
France, Val De Marne | |
Hopital Bicetre | Recruiting |
LE KREMLIN BICETRE, Val De Marne, France, 94275 | |
Contact: PHILIPPE SITBON, MD PhD +33 1 45 21 34 47 philippe.sitbon@bct.aphp.fr | |
Principal Investigator: PHILIPPE SITBON, MD PhD | |
Hopital Henri Mondor | Not yet recruiting |
CRETEIL, Val De Marne, France, 94000 | |
Contact: PIERRE ALBALADEJO, MD PhD +33 1 49 81 43 47 pierre.albaladejo@hmm.aphp.fr | |
Principal Investigator: PIERRE ALBALADEJO, MD PhD | |
France, VIENNE | |
Centre Hospitalier Universitaire De Poitiers | Recruiting |
POITIERS, VIENNE, France, 86000 | |
Contact: DAVID CLEVENOT, MD PhD + 33 5 49 44 38 95 d.clevenot@chu-poitiers.fr | |
Principal Investigator: DAVID CLEVENOT, MD PhD | |
Sub-Investigator: ARNAUD JEANNY, MD PhD |
Principal Investigator: | bernard CHOLLEY, MD PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris ( Bernard CHOLLEY ) |
Study ID Numbers: | P051009, AOM 05086 |
Study First Received: | March 6, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00444262 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority |
Hemodynamic optimisation Esophageal Doppler Hydroxy ethyl starch Hip fracture |
Outcome Hip fracture Elderly subjects (³70 year old) General anesthesia |
Hip Fractures Femoral Fractures Esophageal disorder Cerebral Infarction Fractures, Bone Stroke |
Wounds and Injuries Disorders of Environmental Origin Leg Injuries Hetastarch Esophageal Diseases |
Hip Injuries |