Stroke Volume Optimisation in Patients With Hip Fracture

Phase 3TerminatedNCT00444262

Assistance Publique - Hôpitaux de Paris215 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

215

Conditions

Hip Fractures

Interventions

hemodynamic optimisation guided using esophageal DopplerPROCEDURE

hemodynamic optimisation guided using esophageal Doppler

VOLUVEN and others soluteDRUG

VOLUVEN and others solute

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (19)

Centre Hospitalier Universitaire de La Cote de Nacre

Caen, Calvados, France

Hopital Purpan

Toulouse, Haute Garonne, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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