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

August 7, 2018 updated by: Sara Tantholdt-Hansen, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1967

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders 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.

Description

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.

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: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission to intensive care
Time Frame: 30 days
yes/no
30 days
Length of hospital stay
Time Frame: 30 days
in days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Study Chair: Christian S Meyhoff, MD, PhD, Department of Aneasthesia and Intensive Care, Bispebjerg Hospital

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

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 (Actual)

January 1, 2014

Primary Completion (Actual)

January 30, 2015

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Preoperative sepsis 2017

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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