NCT04042636

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
859

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

5 years

First QC Date

July 31, 2019

Last Update Submit

July 31, 2019

Conditions

Keywords

traumaCLABSI

Outcome Measures

Primary Outcomes (1)

  • Risk factor for bacteremia after trauma

    finding fisk factor for bacteremia in traumatic patients

    5 years

Secondary Outcomes (1)

  • Etiology of bacteremia after trauma

    5 years

Study Arms (2)

1

Patients with Bacteremia after trauma

2

Patients with non-bacteremia after trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Asan Medical Center with trauma from January 2011 to December 2015

You may qualify if:

  • The patients who admitted to intensive care unit (ICU) or general ward (GW) through the emergency department after trauma were studied

You may not qualify if:

  • Patients who arrived on dead-on arrival

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakjae Lee

Seoul, South Korea

Location

Related Publications (4)

  • 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.

  • Antonelli 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.

  • Menges 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.

  • Niven 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.

MeSH Terms

Conditions

BacteremiaWounds and Injuries

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

January 1, 2011

Primary Completion

December 31, 2015

Study Completion

December 31, 2018

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations