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

February 7, 2017 updated by: Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries

This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Sachsen
  - Leipzig, Sachsen, Germany, 04129
    - Klinikum St. Georg gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Group 1: patients who undergo major abdominal surgery Group 2: patients following severe burn injury

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of infections Time Frame: day 28 post intervention	day 28 post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum St. Georg gGmbH

Collaborators

Martin-Luther-Universität Halle-Wittenberg

Investigators

Principal Investigator: Armin R Sablotzki, MD, Klinikum St. Georg gGmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria