Clinical trial NCT00444262: Stroke Volume Optimisation in Patients With Hip Fracture
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hip Fractures
Keywords: Hemodynamic optimisation
Esophageal Doppler
Hydroxy ethyl starch
Hip fracture
Outcome
Elderly subjects (≥ 70 year old)
General anesthesia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
name: GAMIDA
First posted: 2007-03-07
Enrollment: 215
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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
timeFrame: during hospitalisation in acute care
Secondary outcomes:
measure: 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
timeFrame: at 3 months and at one year
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Hospitalier Universitaire de La Cote de Nacre
state: Calvados
city: Toulouse
country: France
facility: Hopital Purpan
state: Haute Garonne
city: Clamart
country: France
facility: Hopital Antoine Beclere
state: Hauts de Seine
city: Clamart
country: France
facility: Hopital D'Instruction Des Armees Percy
state: Hauts de Seine
city: Clichy
country: France
facility: Hopital Beaujon
state: Hauts de Seine
city: Montpellier
country: France
facility: Hopital Lapeyronie
state: Herault
city: Meaux
country: France
facility: Centre Hospitalier de Meaux
state: Seine Et Marne
city: Rouen
country: France
facility: Centre Hospitalier Universitaire Rouen
state: Seine Maritime
city: Bobigny
country: France
facility: Hopital Avicenne
state: Seine Saint Denis
city: Creteil
country: France
facility: Hopital Henri Mondor
state: Val de Marne
city: Le Kremlin Bicetre
country: France
facility: Hopital Bicetre
state: Val de Marne
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
state: Vienne
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
city: Paris
country: France
facility: Fondation Saint Joseph
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: bernard CHOLLEY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: