Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury

NCT ID: NCT01055587

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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Conditions

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Third Degree Burn Second Degree Burn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

severe burn injury

The investigators compare levels of biomarkers within the first 20 days in patients with and without complications following severe burn injury

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role collaborator

Klinikum St. Georg gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Armin Sablotzki, MD

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Armin R Sablotzki, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum St. Georg gGmbH

Locations

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Klinikum St. Georg gGmbH

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 31075618 (View on PubMed)

Gille 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.

Reference Type DERIVED
PMID: 28221298 (View on PubMed)

Other Identifiers

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Stu09/0031

Identifier Type: -

Identifier Source: secondary_id

EK-BR-29/09-1

Identifier Type: -

Identifier Source: org_study_id

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