- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807039
Mortality Following Surgery for Proximal Femoral Fractures (HipMo)
July 22, 2016 updated by: Petr Štourač, MD, Brno University Hospital
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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)
Study Type
Observational
Enrollment (Actual)
369
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jihomoravský Kraj
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Brno, Jihomoravský Kraj, Czech Republic, 62500
- Faculty hospital Brno
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
isolated fracture of proximal femur indicated for surgery
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients after surgery with isolated proximal femur fracture
Patients between 18-110 years admitted to Faculty Hospital Brno with isolated injury of proximal femur (ICD dg.
S72.0 a S72.1)who underwent surgery between 1.1.
2011 00:00 - 31.12.
2012 23:59 in Faculty hospital Brno (tertiary care university hospital).
|
we evaluate the relationship between the monitored parameters and 30 day survival
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in hospital mortality rate
Time Frame: 2 years
|
number of deaths from hospital admission to discharge (percent)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 days mortality rate
Time Frame: 2 years
|
number of deaths within 30 days after injury (percent)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Petr Štourač, MD, Ph.D., Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
March 6, 2013
First Submitted That Met QC Criteria
March 7, 2013
First Posted (Estimate)
March 8, 2013
Study Record Updates
Last Update Posted (Estimate)
July 26, 2016
Last Update Submitted That Met QC Criteria
July 22, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KARIM FN Brno
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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