Stroke Volume Optimisation in Patients With Hip Fracture

Hip Fractures Clinical Trial

— FRACTALE  

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 "

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00444262
• Other study ID #: P051009-AOM 05086
• Status: Terminated
• Phase: Phase 3
• First received: March 6, 2007
• Last updated: October 6, 2011
• Start date: April 2007
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 215
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• hemodynamic optimisation guided using esophageal Doppler
hemodynamic optimisation guided using esophageal Doppler

Drug:
• VOLUVEN and others solute
VOLUVEN and others solute

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny	Seine Saint Denis
France	Centre Hospitalier Universitaire de La Cote de Nacre	Caen	Calvados
France	Hopital Antoine Beclere	Clamart	Hauts de Seine
France	Hopital D'Instruction Des Armees Percy	Clamart	Hauts de Seine
France	Hopital Beaujon	Clichy	Hauts de Seine
France	Hopital Henri Mondor	Creteil	Val de Marne
France	Hopital Bicetre	Le Kremlin Bicetre	Val de Marne
France	Centre Hospitalier de Meaux	Meaux	Seine Et Marne
France	Hopital Lapeyronie	Montpellier	Herault
France	Fondation Saint Joseph	Paris
France	Hopital Bichat	Paris
France	Hopital Cochin	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital La Pitie Salpetriere	Paris
France	Hopital Lariboisiere	Paris
France	Hopital Saint Antoine	Paris
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	Centre Hospitalier Universitaire Rouen	Rouen	Seine Maritime
France	Hopital Purpan	Toulouse	Haute Garonne

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fresenius Kabi, GAMIDA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		during hospitalisation in acute care	Yes
Secondary	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		at 3 months and at one year	Yes