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

Completed

• Conditions: Sepsis; Hip Fractures
• Interventions: Procedure: Repair of hip fracture

• Registration Number: NCT03201679
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-01-01
• Primary Completion: 2015-01-30
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Completion: 2017-08-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1967

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with preoperative sepsis	Repair of hip fracture	Sepsis defined as SIRS plus a positive culture from any site.
Patients without preoperative sepsis	Repair of hip fracture	-

Primary Outcome Measures

Name	Time	Method
Mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Admission to intensive care	30 days	yes/no
Length of hospital stay	30 days	in days