INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery

Completed

• Conditions: Systemic Inflammatory Response Syndrome
• Interventions: Procedure: cardiac surgery with CPB use

• Registration Number: NCT01020409
• Lead Sponsor: Medical University of Gdansk

Brief Summary

The aim of the study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of inflammatory response related complications in patients undergoing heart surgery with use of cardiopulmonary bypass.

Detailed Description

Identified so far predictors of mortality and/or morbidity in patients who undergo heart surgery with cardiopulmonary bypass (CPB), used in previous risk prediction models (EUROSCORE, CABDEAL, Cleveland), will be compared with new candidate variables:

1. anamnestic: recent tooth extractions, chronic inflammatory diseases, specific drug use;

2. biochemical: C-reacting protein, interleukin-6, tumor necrosing factor alpha;

3. genetical: single nucleotide polymorphisms of 10 genes associated with inflammatory response; and

4. clinical from the 1. postoperative day: systemic inflammatory response syndrome, APACHE-III score;

against their predictive capability of selected clinical phenotypes of inflammatory response occuring after surgery, beginning from day 2. after surgery.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2011-04
• Study Completion: 2012-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

• adults (age >=18)
• given and signed informed consent
• no previous cardiac surgery with opening the pericardium

Exclusion Criteria

• previous cardiac surgery with opening the pericardium
• consent refused or not given

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac surgery with CPB use	cardiac surgery with CPB use	Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.

Primary Outcome Measures

Name	Time	Method
Clinical phenotypes of inflammatory response: SIRS, acute lung injury/acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, perioperative myocardial infarct/injury, sepsis.	between day 2 after operation and hospital discharge

Secondary Outcome Measures

Name	Time	Method
all cause inhospital mortality	from day 2 after operation

Trial Locations

Locations (1)

Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology; 🇵🇱 Gdańsk, Poland