Immunophenotyping of Patients With Postoperative SIRS

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02957175
• Other study ID #: BOST-001
• Status: Recruiting
• Start date: November 2016
• Est. completion date: May 2021

Study information

• Verified date: April 2020
• Source: University of Bonn
• Contact: Christian Bode, MD
• Phone: +4922828714119
• Email: christian.bode[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Systemic Inflammatory Response Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification)		30 days
Secondary	Number of participants with infection as assessed by microbiological, serological and radiological examination		30 days
Secondary	Number of participants with postoperative delir as assessed by CAM-ICU		30 days
Secondary	Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels		30 days
Secondary	Number of participants with new atrial fibrillation as assessed by ECG		30 days
Secondary	Length of stay in ICU		30 days
Secondary	Length of stay in hospital		30 days
Secondary	In-hospital mortality		30 days

External Links

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