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CompletedNCT03201679Updated Aug 8, 2018

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

An observational study in Sepsis and Hip Fractures, sponsored by Bispebjerg Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Bispebjerg Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,967
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sepsis
  • Hip Fractures

Keywords

  • SIRS, systemic inflammatory response syndrome
  • Hip Fracture Surgery
  • Sepsis
  • Mortality
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In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's enrollment of 1,967 is above the median of 160 across 957 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,967 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureRepair of hip fracture

    Patients undergoing hip fracture surgery

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What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 30 days

Secondary outcomes

  1. Admission to intensive care

    yes/no

    Time frame: 30 days

  2. Length of hospital stay

    in days

    Time frame: 30 days

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24895018 ↗
  • 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. PubMed 23982637 ↗
  • 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. PubMed 17141780 ↗
  • 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. PubMed 21683355 ↗
  • 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. PubMed 28238106 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2014 to primary completion in Jan 2015, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2017
First posted
Jun 28, 2017
StartActual
Jan 1, 2014
Primary completionActual
Jan 30, 2015
CompletionActual
Aug 1, 2017
Last update
Aug 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03201679
Responsible party
Sara Tantholdt-Hansen (Medical student, Bispebjerg Hospital) — Principal investigator
First posted
Jun 28, 2017
Start date
Jan 1, 2014
Primary completion
Jan 30, 2015
Completion
Aug 1, 2017
Last update
Aug 8, 2018

Study contacts

Christian S Meyhoff, MD, PhD
study chair · Department of Aneasthesia and Intensive Care, Bispebjerg Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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