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termination of the study due to difficulties to include patients
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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
| GAMIDA | UNKNOWN |
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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.
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 (VoluvenÂź) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | conventional treatment |
|
| 2 | Experimental | stroke volume optimisation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemodynamic optimisation guided using esophageal Doppler | Procedure | hemodynamic optimisation guided using esophageal Doppler |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| bernard CHOLLEY, MD PhD | Assistance Publique - HĂŽpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de La Cote de Nacre | Caen | Calvados | 14000 | France | ||
| Hopital Purpan |
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| VOLUVEN and others solute | Drug | VOLUVEN and others solute |
|
| Toulouse |
| Haute Garonne |
| 31000 |
| France |
| Hopital Antoine Beclere | Clamart | Hauts de Seine | 92140 | France |
| Hopital D'Instruction Des Armees Percy | Clamart | Hauts de Seine | 92140 | France |
| Hopital Beaujon | Clichy | Hauts de Seine | 92110 | France |
| Hopital Lapeyronie | Montpellier | Herault | 34000 | France |
| Hopital Lariboisiere | Paris | Paris | 75010 | France |
| Hopital Saint Antoine | Paris | Paris | 75012 | France |
| Hopital La Pitie Salpetriere | Paris | Paris | 75013 | France |
| Fondation Saint Joseph | Paris | Paris | 75014 | France |
| Hopital Cochin | Paris | Paris | 75014 | France |
| Hopital Europeen Georges Pompidou | Paris | Paris | 75015 | France |
| Hopital Bichat | Paris | Paris | 75018 | France |
| Centre Hospitalier de Meaux | Meaux | Seine Et Marne | 77100 | France |
| Centre Hospitalier Universitaire Rouen | Rouen | Seine Maritime | 76000 | France |
| Hopital Avicenne | Bobigny | Seine Saint Denis | 93009 | France |
| Hopital Henri Mondor | Créteil | Val de Marne | 94000 | France |
| Hopital Bicetre | Le Kremlin-BicĂȘtre | Val de Marne | 94275 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | Vienne | 86000 | France |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| C485123 | HES 130-0.4 |
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