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The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201679
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Tantholdt-Hansen, Bispebjerg Hospital

Tracking Information
First Submitted Date June 27, 2017
First Posted Date June 28, 2017
Last Update Posted Date August 8, 2018
Actual Study Start Date January 1, 2014
Actual Primary Completion Date January 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2017)
Mortality [ Time Frame: 30 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2017)
  • Admission to intensive care [ Time Frame: 30 days ]
    yes/no
  • Length of hospital stay [ Time Frame: 30 days ]
    in days
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery
Official Title The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery
Brief Summary

The worldwide occurrence of hip fracture is high with an annual incidence of approximately 100 per 100.000 people. Mortality for patients undergoing hip fracture surgery is high with a 30-day mortality rate varying between 4.5 and 13.3 %. It is agreed that non-modifiable factors such as age, gender and pre-existing comorbidities contribute to early death of hip fracture patients. However, not many studies have focused on preoperative sepsis as a potential risk factor. Hip fracture patients are commonly identified with sepsis after surgery, but the extent of preoperative sepsis and its consequences are sparsely elucidated. Being able to identify patients at higher risk of postoperative mortality could potentially improve outcome and extensive hospital registries of vital signs and cultures allow identification of preoperative sepsis.

The aim of this study is to assess the association between preoperative sepsis and the 30-day mortality after hip fracture surgery.

Detailed Description This study will be a retrospective analysis of a set of data collected prospectively. Data on relevant cultures, blood samples, co-morbidities, time to surgery and 30-day mortality will be extracted from patient records and clinical databases to examine the pre- and postoperative status of the patients.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population will consist of patients admitted with a primary diagnosis of hip fracture and who underwent hip fracture surgery between January 1, 2014 and December 31, 2014.
Condition
  • Sepsis
  • Hip Fractures
Intervention Procedure: Repair of hip fracture
Patients undergoing hip fracture surgery
Study Groups/Cohorts
  • Patients with preoperative sepsis
    Sepsis defined as SIRS plus a positive culture from any site.
    Intervention: Procedure: Repair of hip fracture
  • Patients without preoperative sepsis
    Intervention: Procedure: Repair of hip fracture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2017)
1967
Original Actual Enrollment Same as current
Actual Study Completion Date August 1, 2017
Actual Primary Completion Date January 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with one of the following ICD-10 diagnoses for hip fracture: DS720(Fracture of neck of femur), DS721 (Pertrochanteric fracture), DS721A(Intertrochanteric fracture), DS721B (Trochanteric fracture), DS722 (Subtrochanteric fracture)
  • Patients who underwent surgery for hip fracture.
  • Age > 18 years

Exclusion Criteria:

  • Patients with a pathologic hip fracture related to an underlying metastatic disease (ICD-10: DM907).
  • Patients with incomplete preoperative data. All patients must have at least one record of each of the following variables within 72 hours prior to hip fracture surgery: temperature, heartrate, respiratory rate and blood leukocytes.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03201679
Other Study ID Numbers Preoperative sepsis 2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sara Tantholdt-Hansen, Bispebjerg Hospital
Study Sponsor Bispebjerg Hospital
Collaborators Not Provided
Investigators
Study Chair: Christian S Meyhoff, MD, PhD Department of Aneasthesia and Intensive Care, Bispebjerg Hospital
PRS Account Bispebjerg Hospital
Verification Date August 2018