Clinical trial NCT01807039: Mortality Following Surgery for Proximal Femoral Fractures
Official title: Mortality Following Surgery for Proximal Femoral Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of Neck of Femur (Hip)
Keywords: hip fracture
proximal femur
pertrochanteric fracture
subtrochanteric fracture
subcapital fracture
safety issue
anesthesia
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: St. Anne's University Hospital Brno, Czech Republic
First posted: 2013-03-08
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: isolated fracture of proximal femur indicated for surgery

Brief summary: Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).

Detailed description: We evaluate relationship between the monitored parameters and 30 day survival.

Observed parameters:

* age of the patient
* sex of the patient
* 90 days mortality rate
* American Society of Anesthesiologists (ASA) score
* time since injury and surgery (hours)
* whether surgery was initiated during the day (7:00 - 20:00) or at night (20:00-07:00)
* type of administered anesthesia (GA, epidural anaesthesia, Subarachnoid (spinal) block)
* hemoglobin level prior to surgery
* haemotransfusion administration during surgery
* perioperative administration of vasopressors
* anesthetist erudition (with / without accomplished residency)
* surgeon erudition (with / without accomplished residency)

Eligibility criteria: Inclusion Criteria:

* isolated fracture of proximal femur indicated for surgery

Exclusion Criteria:

* children under 18 years
* none isolated trauma
* isolated fracture of proximal femur without surgery

Primary outcomes:
measure: in hospital mortality rate
timeFrame: 2 years
Secondary outcomes:
measure: 30 days mortality rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
state: Jihomoravský Kraj
Study officials:
affiliation: Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
name: Petr Štourač, MD, Ph.D.
role: STUDY_DIRECTOR
References:
citation: O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, Carson JL. The effect of anesthetic technique on postoperative outcomes in hip fracture repair. Anesthesiology. 2000 Apr;92(4):947-57. doi: 10.1097/00000542-200004000-00011.
citation: Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
citation: Dzupa V, Bartonicek J, Skala-Rosenbaum J, Prikazsky V. [Mortality in patients with proximal femoral fractures during the first year after the injury]. Acta Chir Orthop Traumatol Cech. 2002;69(1):39-44. Czech.