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
  Purpose

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: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all cause inhospital mortality [ Time Frame: from day 2 after operation ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
Active Comparator: CPB cardiac surgery
Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020409

Locations
Poland
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
Investigators
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

Publications:

Responsible Party: Maciej M. Kowalik, Dr., Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01020409     History of Changes
Other Study ID Numbers: N N403 1815 34, MUG grant G-35
Study First Received: November 24, 2009
Last Updated: January 8, 2013
Health Authority: Poland: Ministry of Science and Higher Education

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
sepsis

Additional relevant MeSH terms:
Postoperative Complications
Systemic Inflammatory Response Syndrome
Syndrome
Pathologic Processes
Inflammation
Shock
Disease

ClinicalTrials.gov processed this record on September 22, 2014