NCT03201679

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,967

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

June 27, 2017

Last Update Submit

August 7, 2018

Conditions

SepsisHip Fractures

Keywords

SIRS, systemic inflammatory response syndromeHip Fracture SurgerySepsisMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality

    30 days

Secondary Outcomes (2)

  • Admission to intensive care

    30 days

  • Length of hospital stay

    30 days

Study Arms (2)

Patients with preoperative sepsis

Sepsis defined as SIRS plus a positive culture from any site.

Procedure: Repair of hip fracture

Patients without preoperative sepsis

Procedure: Repair of hip fracture

Interventions

Repair of hip fracturePROCEDURE

Patients undergoing hip fracture surgery

Patients with preoperative sepsisPatients without preoperative sepsis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Smith T, Pelpola K, Ball M, Ong A, Myint PK. Pre-operative indicators for mortality following hip fracture surgery: a systematic review and meta-analysis. Age Ageing. 2014 Jul;43(4):464-71. doi: 10.1093/ageing/afu065. Epub 2014 Jun 3.

    PMID: 24895018BACKGROUND

  • Khan MA, Hossain FS, Ahmed I, Muthukumar N, Mohsen A. Predictors of early mortality after hip fracture surgery. Int Orthop. 2013 Nov;37(11):2119-24. doi: 10.1007/s00264-013-2068-1. Epub 2013 Aug 28.

    PMID: 23982637BACKGROUND

  • Deakin DE, Boulton C, Moran CG. Mortality and causes of death among patients with isolated limb and pelvic fractures. Injury. 2007 Mar;38(3):312-7. doi: 10.1016/j.injury.2006.09.024. Epub 2006 Dec 4.

    PMID: 17141780BACKGROUND

  • Hu F, Jiang C, Shen J, Tang P, Wang Y. Preoperative predictors for mortality following hip fracture surgery: a systematic review and meta-analysis. Injury. 2012 Jun;43(6):676-85. doi: 10.1016/j.injury.2011.05.017. Epub 2011 Jun 17.

    PMID: 21683355BACKGROUND

  • Pedersen NE, Rasmussen LS, Petersen JA, Gerds TA, Ostergaard D, Lippert A. A critical assessment of early warning score records in 168,000 patients. J Clin Monit Comput. 2018 Feb;32(1):109-116. doi: 10.1007/s10877-017-0003-5. Epub 2017 Feb 25.

    PMID: 28238106BACKGROUND

MeSH Terms

Conditions

SepsisHip FracturesSystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

InfectionsInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesShock

Study Officials

  • Christian S Meyhoff, MD, PhD

    Department of Aneasthesia and Intensive Care, Bispebjerg Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical student

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 28, 2017

Study Start

January 1, 2014

Primary Completion

January 30, 2015

Study Completion

August 1, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08