Clinical Trials Directory

Trials / Completed

CompletedNCT01020409

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
525 (actual)
Sponsor
Medical University of Gdansk · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcardiac surgery with CPB usecardiac surgery with CPB use or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.

Timeline

Start date
2009-10-01
Primary completion
2011-04-01
Completion
2012-11-01
First posted
2009-11-25
Last updated
2016-11-15

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT01020409. Inclusion in this directory is not an endorsement.