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...
Date First Received: November 24, 2009
Last Updated: November 27, 2009
Verified by: Medical University of Gdansk, November 2009
Clinical Trial Phase: N/A | Start Date: October 2009
Overall Status: Recruiting
Estimated Enrollment: 500
Brief Summary
Official Title: “INFLACOR - Evaluation of Selected Genetic Polymorphisms, Inflammatory Mediators, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: March 2011
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Procedure: cardiac surgery with CPB use
- heart or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.
Arms, Groups and Cohorts in this Clinical Trial
- : CPB cardiac surgery
- Adult patients, who signed the informed consent, undergoing first-time scheduled heart surgery with CPB use.
Outcome Measures for this Clinical Trial
Primary 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
Safety Issue?: No
- Time Frame: between day 2 after operation and hospital discharge
Secondary Measures
- all cause inhospital mortality
- Time Frame: from day 2 after operation
Safety Issue?: No
- Time Frame: from day 2 after operation
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Medical University of Gdansk
Overall Clinical Trial Officials and Contacts
Romuald Lango, MD, PhD Study Chair Medical University of Gdańsk
Overall Contact: Romuald Lango, MD, PhD +48583492483 rlango@gumed.edu.pl
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01020409
Study ID Number: N N403 1815 34
ClinicalTrials.gov Identifier: NCT01020409
Health Authority: Poland: Ministry of Science and Higher Education
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
