BacteremiaNCT04042636
Epidemiologic Patterns of Bacteremia After Trauma
An observational study of Bacteremia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Presence of pelvic and liver injury on arrival in ED, gastrointestinal tract perforation and massive transfusion within the first 24 hours after trauma appear a significant risk factor for bacteremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 859 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2011to 31 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Asan Medical Center with trauma from January 2011 to December 2015
Who may be able to join
- The patients who admitted to intensive care unit (ICU) or general ward (GW) through the emergency department after trauma were studied
Who cannot join
- Patients who arrived on dead-on arrival
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Patterns for Early Onset and Late Onset Bacteremia After Trauma
Presence of pelvic and liver injury on arrival in ED, gastrointestinal tract perforation and massive transfusion within the first 24 hours after trauma appear a significant risk factor for bacteremia. Scoring with the ISS, intra-abdominal and pelvic injury and presence of transfusion and shock at admission to ED appears a useful tool for identifying trauma patients at increased risk of bacteremia.
Read the detailed description
Purpose: Bacteremia is a major nosocomial infection problem in view of its high mortality. Bacteremia occurs in trauma patients frequently and increases a morbidity and mortality. The aim of this study was to identify risk factors and to describe epidemiological patterns for early onset (EOB) and late onset (LOB) bacteremia after trauma.
Methods: All trauma patients admitted to surgical intensive care unit (SICU) and general ward (GW) from January 2011 to December 2015 were retrospectively enrolled. The following information was collected for each patient and recorded in a computer database: demography, severity of trauma according to the Injury Severity Score (ISS) and each abbreviated injury score (AIS), severity of coma according to the Glasgow Coma Scale (GCS), presence of shock and transfusion. Early onset bacteremia was defined as EOB when onset occurred within 7 days after trauma, and late onset bacteremia was defined as LOB when appearing after 7 days from trauma.
- Conditions
- Bacteremia
- Keywords
- trauma, CLABSI
- Medical subject headings
- Bacteremia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Bacteremia after trauma | |
| 2 | Patients with non-bacteremia after trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factor for bacteremia after trauma
finding fisk factor for bacteremia in traumatic patients
Measured: 5 years
Secondary outcomes (1)
Etiology of bacteremia after trauma
distinguishing G(+) cocci, G(-) rod, and candida spp.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jan 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyung, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042636
- Sponsor's protocol ID
- AsanMC-Bacteremia
- Status last verified
- Jul 2019
- First submitted
- 31 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rello J, Ricart M, Mirelis B, Quintana E, Gurgui M, Net A, Prats G. Nosocomial bacteremia in a medical-surgical intensive care unit: epidemiologic characteristics and factors influencing mortality in 111 episodes. Intensive Care Med. 1994;20(2):94-8. doi: 10.1007/BF01707661.
PubMed 8201105Antonelli M, Moro ML, D'Errico RR, Conti G, Bufi M, Gasparetto A. Early and late onset bacteremia have different risk factors in trauma patients. Intensive Care Med. 1996 Aug;22(8):735-41. doi: 10.1007/BF01709514.
PubMed 8880240Menges P, Kessler W, Kloecker C, Feuerherd M, Gaubert S, Diedrich S, van der Linde J, Hegenbart A, Busemann A, Traeger T, Cziupka K, Heidecke CD, Maier S. Surgical trauma and postoperative immune dysfunction. Eur Surg Res. 2012;48(4):180-6. doi: 10.1159/000338196. Epub 2012 May 25.
PubMed 22653168Niven DJ, Fick GH, Kirkpatrick AW, Grant V, Laupland KB. Cost and outcomes of nosocomial bloodstream infections complicating major traumatic injury. J Hosp Infect. 2010 Dec;76(4):296-9. doi: 10.1016/j.jhin.2010.06.004. Epub 2010 Aug 11.
PubMed 20705364
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Patterns for Early Onset and Late Onset Bacteremia After Trauma
- ClinicalTrials.gov ID
- NCT04042636
- Acronym / sponsor ID
- AsanMC-Bacteremia
- Conditions
- Bacteremia
- Keywords
- trauma, CLABSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 859 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Aug 2019 (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.
Presence of pelvic and liver injury on arrival in ED, gastrointestinal tract perforation and massive transfusion within the first 24 hours after trauma appear a significant risk factor for bacteremia. Scoring with the ISS, intra-abdominal and pelvic injury and presence of transfusion and shock at admission to ED appears a useful tool for identifying trauma patients at increased risk of bacteremia.
Detailed description
Purpose: Bacteremia is a major nosocomial infection problem in view of its high mortality. Bacteremia occurs in trauma patients frequently and increases a morbidity and mortality. The aim of this study was to identify risk factors and to describe epidemiological patterns for early onset (EOB) and late onset (LOB) bacteremia after trauma.
Methods: All trauma patients admitted to surgical intensive care unit (SICU) and general ward (GW) from January 2011 to December 2015 were retrospectively enrolled. The following information was collected for each patient and recorded in a computer database: demography, severity of trauma according to the Injury Severity Score (ISS) and each abbreviated injury score (AIS), severity of coma according to the Glasgow Coma Scale (GCS), presence of shock and transfusion. Early onset bacteremia was defined as EOB when onset occurred within 7 days after trauma, and late onset bacteremia was defined as LOB when appearing after 7 days from trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Bacteremia after trauma |
| 2 | – | –Patients with non-bacteremia after trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Asan Medical Center with trauma from January 2011 to December 2015
Key inclusion criteria (1 listed)
- The patients who admitted to intensive care unit (ICU) or general ward (GW) through the emergency department after trauma were studied
Key exclusion criteria (1 listed)
- Patients who arrived on dead-on arrival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factor for bacteremia after trauma
Time frame: 5 years
finding fisk factor for bacteremia in traumatic patients
1 secondary outcome
Etiology of bacteremia after trauma
Time frame: 5 years
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 2 Aug 2019.
- Results publication: PubMed 8201105Rello J, Ricart M, Mirelis B, Quintana E, Gurgui M, Net A, Prats G. Nosocomial bacteremia in a medical-surgical intensive care unit: epidemiologic characteristics and factors influencing mortality in 111 episodes. Intensive Care Med. 1994;20(2):94-8. doi: 10.1007/BF01707661.
- Results publication: PubMed 8880240Antonelli M, Moro ML, D'Errico RR, Conti G, Bufi M, Gasparetto A. Early and late onset bacteremia have different risk factors in trauma patients. Intensive Care Med. 1996 Aug;22(8):735-41. doi: 10.1007/BF01709514.
- Results publication: PubMed 22653168Menges P, Kessler W, Kloecker C, Feuerherd M, Gaubert S, Diedrich S, van der Linde J, Hegenbart A, Busemann A, Traeger T, Cziupka K, Heidecke CD, Maier S. Surgical trauma and postoperative immune dysfunction. Eur Surg Res. 2012;48(4):180-6. doi: 10.1159/000338196. Epub 2012 May 25.
- Results publication: PubMed 20705364Niven DJ, Fick GH, Kirkpatrick AW, Grant V, Laupland KB. Cost and outcomes of nosocomial bloodstream infections complicating major traumatic injury. J Hosp Infect. 2010 Dec;76(4):296-9. doi: 10.1016/j.jhin.2010.06.004. Epub 2010 Aug 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by Asan Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Risk factor for bacteremia after trauma (time frame: 5 years). 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 NCT04042636, which also lists 4 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 2 Aug 2019.