Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury
Earlygnost
Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries
2 other identifiers
observational
120
1 country
1
Brief Summary
This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 8, 2017
February 1, 2017
5.8 years
January 22, 2010
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of infections
day 28 post intervention
Study Arms (2)
major abdominal surgery
The investigators compare the levels of biomarkers in patients with and without complications in the early postoperative course following major abdominal surgery
severe burn injury
The investigators compare levels of biomarkers within the first 20 days in patients with and without complications following severe burn injury
Eligibility Criteria
Group 1: patients who undergo major abdominal surgery Group 2: patients following severe burn injury
You may qualify if:
- patients with major abdominal surgery (e.g. gastrectomy, hemi-/colectomy, resection of sigma or rectum, resection of liver, esophagectomy)
- patients following severe burn injury (burn surface area \>= 15%)
- age \>= 18 years
- informed consent
You may not qualify if:
- no informed consent
- emergency surgery
- immunocompromising diseases (e.g. HIV+, AIDS, Lymphoma or NonHodgkin-Lymphoma, Autoimmune-Diseases)
- pre-existing liver or renal failure
- chronic therapy with corticoids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum St. Georg gGmbH
Leipzig, Saxony, 04129, Germany
Related Publications (2)
Gille J, Schmidt J, Kremer T, Sablotzki A. Evaluation of MR-proANP and copeptin for sepsis diagnosis after burn injury. J Crit Care. 2019 Aug;52:149-155. doi: 10.1016/j.jcrc.2019.04.031. Epub 2019 Apr 30.
PMID: 31075618DERIVEDGille J, Ostermann H, Dragu A, Sablotzki A. MR-proADM: A New Biomarker for Early Diagnosis of Sepsis in Burned Patients. J Burn Care Res. 2017 Sep/Oct;38(5):290-298. doi: 10.1097/BCR.0000000000000508.
PMID: 28221298DERIVED
Biospecimen
plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armin R Sablotzki, MD
Klinikum St. Georg gGmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
September 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 8, 2017
Record last verified: 2017-02