Systemic Inflammatory Response Syndrome
Conditions
Keywords
Immunophenotyping, Perioperative Care, Innate Immunity, Cardiac Surgical Procedures
Brief summary
The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.
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.
Interventions
OTHERImmunophenotyping
Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach
Sponsors
University of Bonn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with SIRS as assessed by SOFA-Score | 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
| Measure | Time frame |
|---|---|
| Length of stay in hospital | 30 days |
| In-hospital mortality | 30 days |
| Number of participants with postoperative delir as assessed by CAM-ICU | 30 days |
| Length of stay in ICU | 30 days |
| Number of participants with new atrial fibrillation as assessed by ECG | 30 days |
| 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 myocardial injury as assessed by troponine and CK-MB serum levels | 30 days |
Countries
Germany
Contacts
Primary ContactChristian Bode, MD
Outcome results
None listed