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

This study has been completed.
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:
NCT01055587
First received: January 22, 2010
Last updated: December 27, 2015
Last verified: December 2015
  Purpose
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
Third Degree Burn
Second Degree Burn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries

Resource links provided by NLM:


Further study details as provided by Klinikum St. Georg gGmbH:

Primary Outcome Measures:
  • rate of infections [ Time Frame: day 28 post intervention ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
plasma samples

Enrollment: 120
Study Start Date: September 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: January 22, 2010
Last Updated: December 27, 2015
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Infection
Burns
Wounds and Injuries
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016