SepsisNCT03201679
The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery
An observational study of Sepsis and Hip Fractures, run by Bispebjerg Hospital.
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 %. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hip Fractures
- What is being tested?
- Repair of hip fracture
- Type of treatment
- Surgery or procedure
- How many people
- 1,967 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- Sepsis, Hip Fractures
- Being tested
- Repair of hip fracture
- Keywords
- SIRS, systemic inflammatory response syndrome, Hip Fracture Surgery, Sepsis, Mortality
- Medical subject headings
- Sepsis, Hip Fractures, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of hip fractureProcedure or surgery
Patients undergoing hip fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with preoperative sepsis | Sepsis defined as SIRS plus a positive culture from any site. Receives: Procedure: Repair of hip fracture | |
| Patients without preoperative sepsis | Not described Receives: Procedure: Repair of hip fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Secondary outcomes (2)
Admission to intensive care
yes/no
Measured: 30 days
Length of hospital stay
in days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jan 2014
- Primary completion30 Jan 2015
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Tantholdt-Hansen, Bispebjerg Hospital
- Investigators
- Christian S Meyhoff, MD, PhD, Study chair, Department of Aneasthesia and Intensive Care, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201679
- Sponsor's protocol ID
- Preoperative sepsis 2017
- Status last verified
- Aug 2018
- First submitted
- 27 Jun 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24895018Khan 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 23982637Deakin 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 17141780Hu 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 21683355Pedersen 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT03201679
- Acronym / sponsor ID
- Preoperative sepsis 2017
- Conditions
- Sepsis, Hip Fractures
- Keywords
- SIRS, systemic inflammatory response syndrome, Hip Fracture Surgery, Sepsis, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,967 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with preoperative sepsis | – | Procedure: Repair of hip fractureSepsis defined as SIRS plus a positive culture from any site. |
| Patients without preoperative sepsis | – | Procedure: Repair of hip fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair of hip fracturePatients undergoing hip fracture surgery | Procedure or surgery | Patients with preoperative sepsis, Patients without preoperative sepsis |
Primary outcome
Mortality
Time frame: 30 days
2 secondary outcomes
Admission to intensive care
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 24895018Smith 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.
- Background: PubMed 23982637Khan 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.
- Background: PubMed 17141780Deakin 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.
- Background: PubMed 21683355Hu 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.
- Background: PubMed 28238106Pedersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Meyhoff, MD, PhD study chair
Department of Aneasthesia and Intensive Care, Bispebjerg Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Hip Fractures, run by Bispebjerg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201679, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.