Stroke Volume Optimisation in Patients With Hip Fracture

Phase 3

Terminated

• Conditions: Hip Fractures
• Interventions: Drug: VOLUVEN and others solute; Procedure: hemodynamic optimisation guided using esophageal Doppler

• Registration Number: NCT00444262
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-06
• Study First Posted: 2007-03-07
• Study Start: 2007-04
• Primary Completion: 2010-11
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	VOLUVEN and others solute	conventional treatment
2	hemodynamic optimisation guided using esophageal Doppler	stroke volume optimisation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (19)

Centre Hospitalier Universitaire de La Cote de Nacre; 🇫🇷 Caen, Calvados, France

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, Vienne, France

Hopital La Pitie Salpetriere; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Bichat; 🇫🇷 Paris, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Fondation Saint Joseph; 🇫🇷 Paris, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Hopital Beaujon; 🇫🇷 Clichy, Hauts de Seine, France

Hopital D'Instruction Des Armees Percy; 🇫🇷 Clamart, Hauts de Seine, France

Hopital Purpan; 🇫🇷 Toulouse, Haute Garonne, France

Hopital Antoine Beclere; 🇫🇷 Clamart, Hauts de Seine, France

Hopital Lapeyronie; 🇫🇷 Montpellier, Herault, France

Centre Hospitalier Universitaire Rouen; 🇫🇷 Rouen, Seine Maritime, France

Centre Hospitalier de Meaux; 🇫🇷 Meaux, Seine Et Marne, France

Hopital Avicenne; 🇫🇷 Bobigny, Seine Saint Denis, France

Hopital Henri Mondor; 🇫🇷 Creteil, Val de Marne, France

Hopital Bicetre; 🇫🇷 Le Kremlin Bicetre, Val de Marne, France

Hopital Lariboisiere; 🇫🇷 Paris, France