Stroke Volume Optimisation in Patients With Hip Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

conventional treatment

Group Type ACTIVE_COMPARATOR

VOLUVEN and others solute

Intervention Type DRUG

VOLUVEN and others solute

2

stroke volume optimisation

Group Type EXPERIMENTAL

hemodynamic optimisation guided using esophageal Doppler

Intervention Type PROCEDURE

hemodynamic optimisation guided using esophageal Doppler

Interventions

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hemodynamic optimisation guided using esophageal Doppler

Intervention Type PROCEDURE

VOLUVEN and others solute

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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bernard CHOLLEY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

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P051009-AOM 05086

Identifier Type: -

Identifier Source: org_study_id

Stroke Volume Optimisation in Patients With Hip Fracture

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

1

VOLUVEN and others solute

2

hemodynamic optimisation guided using esophageal Doppler

Interventions

hemodynamic optimisation guided using esophageal Doppler

VOLUVEN and others solute

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fresenius Kabi

GAMIDA

Assistance Publique - Hôpitaux de Paris

Responsible Party

Principal Investigators

bernard CHOLLEY, MD PhD

Locations

Centre Hospitalier Universitaire de La Cote de Nacre

Hopital Purpan

Hopital Antoine Beclere

Hopital D'Instruction Des Armees Percy

Hopital Beaujon

Hopital Lapeyronie

Hopital Lariboisiere

Hopital Saint Antoine

Hopital La Pitie Salpetriere

Fondation Saint Joseph

Hopital Cochin

Hopital Europeen Georges Pompidou

Hopital Bichat

Centre Hospitalier de Meaux

Centre Hospitalier Universitaire Rouen

Hopital Avicenne

Hopital Henri Mondor

Hopital Bicetre

Centre Hospitalier Universitaire de Poitiers

Countries

Other Identifiers

P051009-AOM 05086