Immunophenotyping of Patients With Postoperative SIRS

• Conditions: Systemic Inflammatory Response Syndrome
• Interventions: Other: Immunophenotyping

• Registration Number: NCT02957175
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-09-30
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• Age < 18 years
• Missing informed consent
• Renal failure
• Liver failure
• Neurodegenerative disease
• Malignancies
• Immune therapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients that develop no SIRS	Immunophenotyping	Immunophenotyping of patients that develop no SIRS after heart surgery
Patients that develop SIRS	Immunophenotyping	Immunophenotyping of patients that develop SIRS after heart surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of stay in ICU	30 days
Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels	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 postoperative delir as assessed by CAM-ICU	30 days
Number of participants with new atrial fibrillation as assessed by ECG	30 days
In-hospital mortality	30 days
Length of stay in hospital	30 days

Trial Locations

Locations (1)

University Hospital Bonn; 🇩🇪 Bonn, Germany