Clinical trial NCT01020409: INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery
Official title: INFLACOR (INFLA-mmation A-fter C-ardiac O-pe-R-ation) - Use of Selected Genetic Variants, Cytokines, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome
Keywords: cardiac surgery
cardiopulmonary bypass
acute lung injury
acute respiratory distress syndrome
acute kidney injury
atrial fibrillation
postoperative psychosis
myocardial infarct
sepsis
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2009-11-25
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults (at least age 18), who signed informed consent, scheduled for elective cardiac surgery with use of cardiopulmonary bypass.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: between day 2 after operation and hospital discharge
Secondary outcomes:
measure: all cause inhospital mortality
timeFrame: from day 2 after operation
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology
Study officials:
affiliation: Medical University of Gdansk
name: Romuald Lango, MD, PhD
role: STUDY_CHAIR
affiliation: Medical University of Gdansk
name: Maciej M Kowalik, MD, PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Gdansk
name: Jan Rogowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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