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

This study has been completed.
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Maciej M. Kowalik, Medical University of Gdansk Identifier:
First received: November 24, 2009
Last updated: November 14, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Systemic Inflammatory Response Syndrome
Procedure: cardiac surgery with CPB use
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • 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. [ Time Frame: between day 2 after operation and hospital discharge ]

Secondary Outcome Measures:
  • all cause inhospital mortality [ Time Frame: from day 2 after operation ]

Biospecimen Retention:   Samples With DNA
plasma, serum, and blood morphologic elements after centrifugation frozen to -75C.

Enrollment: 525
Study Start Date: October 2009
Study Completion Date: November 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cardiac surgery with CPB use
Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
Procedure: cardiac surgery with CPB use
cardiac surgery with CPB use or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.
Other Names:
  • heart valve surgery
  • open heart surgery

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01020409

Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology
Gdańsk, Poland, PL-80-211
Sponsors and Collaborators
Medical University of Gdansk
Ministry of Science and Higher Education, Poland
Study Chair: Romuald Lango, MD, PhD Medical University of Gdańsk
Study Director: Maciej M Kowalik, MD, PhD Medical University of Gdańsk
Principal Investigator: Jan Rogowski, MD, PhD Medical University of Gdańsk
  More Information


Responsible Party: Maciej M. Kowalik, Dr., Medical University of Gdansk Identifier: NCT01020409     History of Changes
Other Study ID Numbers: N N403 1815 34
MUG grant G-35 ( Other Identifier: Medical University of Gdańsk )
Study First Received: November 24, 2009
Last Updated: November 14, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: IPD can be made available to other researcher upon reasonable request.

Keywords provided by Medical University of Gdansk:
cardiac surgery
cardiopulmonary bypass
acute lung injury
acute respiratory distress syndrome
acute kidney injury
atrial fibrillation
postoperative psychosis
myocardial infarct

Additional relevant MeSH terms:
Postoperative Complications
Systemic Inflammatory Response Syndrome
Pathologic Processes
Shock processed this record on May 25, 2017