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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02957175
Other study ID # BOST-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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