Stroke Volume Optimisation in Patients With Hip Fracture (FRACTALE)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

Hip Fractures

Treatments

Drug: VOLUVEN and others solute

Procedure: hemodynamic optimisation guided using esophageal Doppler

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00444262

P051009-AOM 05086

Details and patient eligibility

About

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.

Full 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.

Enrollment

215 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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