Stroke Volume Optimisation in Patients With Hip Fracture

Study Overview
=================
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.

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 

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: hemodynamic optimisation guided using esophageal Doppler
* Drug: VOLUVEN and others solute


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>conventional treatment | Drug: VOLUVEN and others solute<br>* VOLUVEN and others solute<br>|
| Experimental: 2<br>stroke volume optimisation | Procedure: hemodynamic optimisation guided using esophageal Doppler<br>* hemodynamic optimisation guided using esophageal Doppler<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodynamic optimisation, Esophageal Doppler, Hydroxy ethyl starch, Hip fracture, Outcome, Elderly subjects (≥ 70 year old), General anesthesia