Immunophenotyping of Patients With Postoperative SIRS

NCT ID: NCT02957175

Last Updated: 2020-04-24

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-05-31

Brief Summary

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The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.

Detailed Description

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The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.

Conditions

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Systemic Inflammatory Response Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients that develop SIRS

Immunophenotyping of patients that develop SIRS after heart surgery

Immunophenotyping

Intervention Type OTHER

Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach

Patients that develop no SIRS

Immunophenotyping of patients that develop no SIRS after heart surgery

Immunophenotyping

Intervention Type OTHER

Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach

Interventions

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Immunophenotyping

Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Informed consent of the patient
* Patient undergoing a open heart surgery using a cardiopulmonary bypass

Exclusion Criteria

* Age \< 18 years
* Missing informed consent
* Renal failure
* Liver failure
* Neurodegenerative disease
* Malignancies
* Immune therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bonn

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christian Bode

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eicke Latz, MD, PhD

Role: STUDY_CHAIR

Institute of Innate Immunity

Christian Bode, MD

Role: STUDY_CHAIR

Department of Anesthesia and Critical Care Medicine

Folkert M Steinhagen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Critical Care Medicine

Locations

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University Hospital Bonn

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Bode, MD

Role: CONTACT

+4922828714119

Facility Contacts

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Chrisitan Bode, MD

Role: primary

+4922828714119

Related Links

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Other Identifiers

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BOST-001

Identifier Type: -

Identifier Source: org_study_id

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