Stroke Volume Optimisation in Patients With Hip Fracture (FRACTALE)

October 6, 2011 updated by: Assistance Publique - Hôpitaux de Paris

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 "

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

215

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75010
        • Hôpital Lariboisiere
      • Paris, France, 75012
        • Hôpital Saint Antoine
      • Paris, France, 75014
        • Hôpital Cochin
      • Paris, France, 75018
        • Hopital Bichat
      • Paris, France, 75013
        • Hôpital La Pitié Salpêtrière
      • Paris, France, 75014
        • Fondation Saint Joseph
    • Calvados
      • Caen, Calvados, France, 14000
        • Centre Hospitalier Universitaire de La Cote de Nacre
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31000
        • Hopital Purpan
    • Hauts de Seine
      • Clamart, Hauts de Seine, France, 92140
        • Hôpital Antoine Béclère
      • Clamart, Hauts de Seine, France, 92140
        • Hôpital d'instruction des armées Percy
      • Clichy, Hauts de Seine, France, 92110
        • Hôpital Beaujon
    • Herault
      • Montpellier, Herault, France, 34000
        • Hopital Lapeyronie
    • Seine Et Marne
      • Meaux, Seine Et Marne, France, 77100
        • Centre Hospitalier de Meaux
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76000
        • Centre Hospitalier Universitaire Rouen
    • Seine Saint Denis
      • Bobigny, Seine Saint Denis, France, 93009
        • Hôpital Avicenne
    • Val de Marne
      • Creteil, Val de Marne, France, 94000
        • Hopital Henri Mondor
      • Le Kremlin Bicetre, Val de Marne, France, 94275
        • Hopital Bicetre
    • Vienne
      • Poitiers, Vienne, France, 86000
        • Centre Hospitalier Universitaire De Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during hospitalisation in acute care

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 3 months and at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fresenius Kabi
GAMIDA

Investigators

  • Principal Investigator: bernard CHOLLEY, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 6, 2007

First Posted (Estimate)

March 7, 2007

Study Record Updates

Last Update Posted (Estimate)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051009-AOM 05086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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