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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01807039
Other study ID # KARIM FN Brno
Secondary ID
Status Completed
Phase N/A
First received March 6, 2013
Last updated July 22, 2016
Start date December 2012
Est. completion date May 2015

Study information

Verified date July 2016
Source Brno University Hospital
Contact n/a
Is FDA regulated No
Health authority Institute of Biostatistics and Analyses, Masaryk University - University Campus Bohunice (Kamenice 126/3), Brno: Czech Republic
Study type Observational

Clinical Trial 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).


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)


Recruitment information / eligibility

Status Completed
Enrollment 369
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 110 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Procedure:
hip fracture surgery
we evaluate the relationship between the monitored parameters and 30 day survival

Locations

Country Name City State
Czech Republic Faculty Hospital Brno Brno Jihomoravský Kraj

Sponsors (2)

Lead Sponsor Collaborator
Brno University Hospital St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

References & Publications (3)

Dzupa V, Bartonícek J, Skála-Rosenbaum J, Príkazský 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary in hospital mortality rate number of deaths from hospital admission to discharge (percent) 2 years Yes
Secondary 30 days mortality rate number of deaths within 30 days after injury (percent) 2 years Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05548257 - Mortality and Related Risk Factors After Hip Arthroplasty

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