Stroke Volume Optimisation in Patients With Hip Fracture (FRACTALE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444262
Recruitment Status : Terminated (termination of the study due to difficulties to include patients)
First Posted : March 7, 2007
Last Update Posted : October 7, 2011
Fresenius Kabi
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Hip Fractures Procedure: hemodynamic optimisation guided using esophageal Doppler Drug: VOLUVEN and others solute Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 "
Study Start Date : April 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : March 2011

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U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: at 3 months and at one year ]

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444262

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
Hopital Lariboisiere
Paris, France, 75010
Hopital Saint Antoine
Paris, France, 75012
Hopital La Pitie Salpetriere
Paris, France, 75013
Fondation Saint Joseph
Paris, France, 75014
Hopital Cochin
Paris, France, 75014
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Bichat
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fresenius Kabi
Principal Investigator: bernard CHOLLEY, MD PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00444262     History of Changes
Other Study ID Numbers: P051009-AOM 05086
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: June 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hemodynamic optimisation
Esophageal Doppler
Hydroxy ethyl starch
Hip fracture
Elderly subjects (≥ 70 year old)
General anesthesia

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries