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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201679
• Other study ID #: Preoperative sepsis 2017
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1967
• Est. completion date: August 1, 2017
• Est. primary completion date: January 30, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Sepsis
• Toxemia

Intervention

Procedure:
• Repair of hip fracture
Patients undergoing hip fracture surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

References & Publications (5)

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. Epub 2006 Dec 4. — View Citation

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. Review. — View Citation

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. — View Citation

Pedersen NE, Rasmussen LS, Petersen JA, Gerds TA, Østergaard 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days
Secondary	Admission to intensive care	yes/no	30 days
Secondary	Length of hospital stay	in days	30 days