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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Maciej M. Kowalik, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT01020409
First received: November 24, 2009
Last updated: January 8, 2013
Last verified: January 2013

November 24, 2009
January 8, 2013
October 2009
April 2011   (final data collection date for primary outcome 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. [ Time Frame: between day 2 after operation and hospital discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01020409 on ClinicalTrials.gov Archive Site
all cause inhospital mortality [ Time Frame: from day 2 after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
INFLACOR - Genetic and Physiologic Predictors of Inflammation Related Complications After Heart Surgery
INFLACOR - Evaluation of Selected Genetic Polymorphisms, Inflammatory Mediators, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Systemic Inflammatory Response Syndrome
Procedure: cardiac surgery with CPB use
heart or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.
Other Names:
  • heart valve surgery
  • open heart surgery
Active Comparator: CPB cardiac surgery
Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
Intervention: Procedure: cardiac surgery with CPB use

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
525
November 2012
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01020409
N N403 1815 34, MUG grant G-35
Yes
Maciej M. Kowalik, Medical University of Gdansk
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
Medical University of Gdansk
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP