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

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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

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.


Condition or disease Intervention/treatment
Sepsis Hip Fractures Procedure: Repair of hip fracture

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.

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Study Type : Observational
Actual Enrollment : 1967 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 30, 2015
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with preoperative sepsis
Sepsis defined as SIRS plus a positive culture from any site.
Procedure: Repair of hip fracture
Patients undergoing hip fracture surgery

Patients without preoperative sepsis Procedure: Repair of hip fracture
Patients undergoing hip fracture surgery




Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Admission to intensive care [ Time Frame: 30 days ]
    yes/no

  2. Length of hospital stay [ Time Frame: 30 days ]
    in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201679


Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Study Chair: Christian S Meyhoff, MD, PhD Department of Aneasthesia and Intensive Care, Bispebjerg Hospital
Publications:
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Responsible Party: Sara Tantholdt-Hansen, Medical student, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03201679    
Other Study ID Numbers: Preoperative sepsis 2017
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Tantholdt-Hansen, Bispebjerg Hospital:
SIRS, systemic inflammatory response syndrome
Hip Fracture Surgery
Sepsis
Mortality
Additional relevant MeSH terms:
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Sepsis
Toxemia
Fractures, Bone
Hip Fractures
Wounds and Injuries
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Femoral Fractures
Hip Injuries
Leg Injuries