Stroke Volume Optimisation in Patients With Hip Fracture (FRACTALE)

This study has been terminated.
(termination of the study due to difficulties to include patients)
Sponsor:
Collaborators:
Fresenius Kabi
GAMIDA
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00444262
First received: March 6, 2007
Last updated: October 6, 2011
Last verified: June 2011
  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 "

Resource links provided by NLM:


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 ]

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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00444262

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
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fresenius Kabi
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
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 July 20, 2014