Hip Fractures
Conditions
Keywords
Hemodynamic optimisation, Esophageal Doppler, Hydroxy ethyl starch, Hip fracture, Outcome, Elderly subjects (≥ 70 year old), General anesthesia
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.
Interventions
PROCEDUREhemodynamic optimisation guided using esophageal Doppler
hemodynamic optimisation guided using esophageal Doppler
DRUGVOLUVEN and others solute
VOLUVEN and others solute
Sponsors
Fresenius Kabi
GAMIDA
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed