Immunophenotyping of Patients With Postoperative SIRS
1 other identifier
observational
50
1 country
1
Brief Summary
The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedApril 24, 2020
April 1, 2020
4.3 years
September 30, 2016
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with SIRS as assessed by SOFA-Score
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.
30 days
Secondary Outcomes (8)
Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification)
30 days
Number of participants with infection as assessed by microbiological, serological and radiological examination
30 days
Number of participants with postoperative delir as assessed by CAM-ICU
30 days
Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels
30 days
Number of participants with new atrial fibrillation as assessed by ECG
30 days
- +3 more secondary outcomes
Study Arms (2)
Patients that develop SIRS
Immunophenotyping of patients that develop SIRS after heart surgery
Patients that develop no SIRS
Immunophenotyping of patients that develop no SIRS after heart surgery
Interventions
Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach
Eligibility Criteria
Patients undergoing open heart surgery.
You may qualify if:
- Age \> 18 years
- Informed consent of the patient
- Patient undergoing a open heart surgery using a cardiopulmonary bypass
You may not qualify if:
- Age \< 18 years
- Missing informed consent
- Renal failure
- Liver failure
- Neurodegenerative disease
- Malignancies
- Immune therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Bonn
Bonn, 53127, Germany
Related Links
Biospecimen
Serum and Leukocytes
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 30, 2016
First Posted
November 7, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2021
Study Completion
May 1, 2021
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share