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

This study is currently recruiting participants.
Verified July 2013 by Klinikum St. Georg gGmbH
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: July 12, 2013
Last verified: July 2013
  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
Major Abdominal Surgery
Severe Burn Injury

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


Estimated Enrollment: 160
Study Start Date: September 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055587

Contacts
Contact: Armin R Sablotzki, MD 00493419092570 armin.sablotzki@sanktgeorg.de
Contact: Elke G Czeslick, MD 00493419094768 elke.czeslick@sanktgeorg.de

Locations
Germany
Klinikum St. Georg gGmbH Recruiting
Leipzig, Sachsen, Germany, 04129
Contact: Armin R Sablotzki, MD    00493419092570    armin.sablotzki@sanktgeorg.de   
Contact: Elke G Czeslick, MD    00493419094768    elke.czeslick@sanktgeorg.de   
Principal Investigator: Armin R Sablotzki, MD         
Sub-Investigator: Claudia Eggert, MD         
Sub-Investigator: Ralf Kleczewski, MD         
Sub-Investigator: Jochen Gille, MD         
Sub-Investigator: Marie Schumann, MD         
Sub-Investigator: Hanfried Ostermann, MD         
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

No publications provided

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: July 12, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014