Stroke Volume Optimisation in Patients With Hip Fracture

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00444262
• Date of registration: 06/03/2007
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Stroke Volume Optimisation in Patients With Hip Fracture FRACTALE
• Scientific 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 "
• Date of first enrolment: April 2007
• Target sample size: 215
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00444262
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: bernard CHOLLEY, MD PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hip Fractures

Intervention(s)

Procedure: hemodynamic optimisation guided using esophageal Doppler

Drug: VOLUVEN and others solute

Primary Outcome(s)

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 Outcome(s)

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]

Secondary ID(s)

P051009-AOM 05086

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GAMIDA

Fresenius Kabi