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

NCT ID: NCT03201679

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1967 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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.

Conditions

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Sepsis Hip Fractures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with preoperative sepsis

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

Repair of hip fracture

Intervention Type PROCEDURE

Patients undergoing hip fracture surgery

Patients without preoperative sepsis

Repair of hip fracture

Intervention Type PROCEDURE

Patients undergoing hip fracture surgery

Interventions

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Repair of hip fracture

Patients undergoing hip fracture surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sara Tantholdt-Hansen

Medical student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian S Meyhoff, MD, PhD

Role: STUDY_CHAIR

Department of Aneasthesia and Intensive Care, Bispebjerg Hospital

References

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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.

Reference Type BACKGROUND
PMID: 24895018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23982637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17141780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21683355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28238106 (View on PubMed)

Other Identifiers

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Preoperative sepsis 2017

Identifier Type: -

Identifier Source: org_study_id

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