Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444262
Status:
TERMINATED
Last Update Posted:
2011-10-07
First Post:
2007-03-06
Brief Title:
Stroke Volume Optimisation in Patients With Hip Fracture
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
termination of the study due to difficulties to include patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRACTALE
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 costsGoals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None