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Stroke Volume Optimisation in Patients With Hip Fracture (FRACTALE)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, January 2009
First Received: March 6, 2007   Last Updated: February 11, 2009   History of Changes
Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
Fresenius AG
GAMIDA
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00444262
  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 III

MedlinePlus related topics: Esophagus Disorders Fractures Hip Injuries and Disorders Hip Replacement
U.S. FDA Resources
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 "

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
1: Active Comparator
conventional treatment
Drug: VOLUVEN and others solute
VOLUVEN and others solute
2: Experimental
stroke volume optimisation
Procedure: hemodynamic optimisation guided using esophageal Doppler
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
Criteria

Inclusion criteria:

  • Elderly subjects (³70 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444262

Contacts
Contact: bernard CHOLLEY, MD PhD 01 49 95 80 84 bernard.cholley@lrb.aphp.fr

Locations
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            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fresenius AG
GAMIDA
Investigators
Principal Investigator: bernard CHOLLEY, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris ( Bernard CHOLLEY )
Study ID Numbers: P051009, AOM 05086
Study First Received: March 6, 2007
Last Updated: February 11, 2009
ClinicalTrials.gov Identifier: NCT00444262     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hemodynamic optimisation
Esophageal Doppler
Hydroxy ethyl starch
Hip fracture
Outcome
Hip fracture
Elderly subjects (³70 year old)
General anesthesia

Study placed in the following topic categories:
Hip Fractures
Femoral Fractures
Cerebral Infarction
Esophageal Disorder
Fractures, Bone
Stroke
Wounds and Injuries
Anesthetics
Disorders of Environmental Origin
Leg Injuries
Hetastarch
Esophageal Diseases

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 06, 2009