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Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury (Earlygnost)

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ClinicalTrials.gov Identifier: NCT01055587
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : February 8, 2017
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH

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.

Condition or disease
Third Degree Burn Second Degree Burn

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries
Study Start Date : September 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. rate of infections [ Time Frame: day 28 post intervention ]

Biospecimen Retention:   Samples Without DNA
plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Group 1: patients who undergo major abdominal surgery Group 2: patients following severe burn injury
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055587


Locations
Germany
Klinikum St. Georg gGmbH
Leipzig, Sachsen, Germany, 04129
Sponsors and Collaborators
Klinikum St. Georg gGmbH
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Armin R Sablotzki, MD Klinikum St. Georg gGmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT01055587     History of Changes
Other Study ID Numbers: EK-BR-29/09-1
Stu09/0031
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:
major abdominal surgery
severe burn injury
infection
diagnostic

Additional relevant MeSH terms:
Infection
Burns
Wounds and Injuries