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Immunophenotyping of Patients With Postoperative SIRS

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ClinicalTrials.gov Identifier: NCT02957175
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christian Bode, University of Bonn

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

Condition or disease Intervention/treatment
Systemic Inflammatory Response Syndrome Other: Immunophenotyping

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)
Actual Study Start Date : November 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Patients that develop SIRS
Immunophenotyping of patients that develop SIRS after heart surgery
Other: Immunophenotyping
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
Other: Immunophenotyping
Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach




Primary Outcome Measures :
  1. Number of participants with SIRS as assessed by SOFA-Score [ Time Frame: 30 days ]

    The study investigates the relationship between the intra-individual inflammatory patterns in patients with uncomplicated (no SIRS) and complicated postoperative courses (SIRS) after open heart surgery.

    The diagnosis of SIRS will be made by using the Sepsis-related Organ Failure Assessment score (SOFA-score). Patients with an increase in SOFA-score >3 are considered to have SIRS.



Secondary Outcome Measures :
  1. Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification) [ Time Frame: 30 days ]
  2. Number of participants with infection as assessed by microbiological, serological and radiological examination [ Time Frame: 30 days ]
  3. Number of participants with postoperative delir as assessed by CAM-ICU [ Time Frame: 30 days ]
  4. Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels [ Time Frame: 30 days ]
  5. Number of participants with new atrial fibrillation as assessed by ECG [ Time Frame: 30 days ]
  6. Length of stay in ICU [ Time Frame: 30 days ]
  7. Length of stay in hospital [ Time Frame: 30 days ]
  8. In-hospital mortality [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA
Serum and Leukocytes


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing open heart surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957175


Contacts
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Contact: Christian Bode, MD +4922828714119 christian.bode@ukb.uni-bonn.de

Locations
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Germany
University Hospital Bonn Recruiting
Bonn, Germany, 53127
Contact: Chrisitan Bode, MD    +4922828714119    christian.bode@ukb.uni-bonn.de   
Sponsors and Collaborators
University of Bonn
Investigators
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Study Chair: Eicke Latz, MD, PhD Institute of Innate Immunity
Study Chair: Christian Bode, MD Department of Anesthesia and Critical Care Medicine
Principal Investigator: Folkert M Steinhagen, MD Department of Anesthesia and Critical Care Medicine

Additional Information:
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Responsible Party: Dr. Christian Bode, Principal Investigator, University of Bonn
ClinicalTrials.gov Identifier: NCT02957175     History of Changes
Other Study ID Numbers: BOST-001
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Christian Bode, University of Bonn:
Immunophenotyping
Perioperative Care
Innate Immunity
Cardiac Surgical Procedures
Additional relevant MeSH terms:
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Syndrome
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Inflammation
Shock