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Stroke Volume Optimisation in Patients With Hip Fracture

2014-07-23 21:30:01 | BioPortfolio

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.

Study Design

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

Conditions

Hip Fractures

Intervention

hemodynamic optimisation guided using esophageal Doppler, VOLUVEN and others solute

Location

Centre Hospitalier Universitaire de La Cote de Nacre
Caen
Calvados
France
14000

Status

Recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:30:01-0400

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