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

Medical University of Gdansk

Status: Completed

Conditions: Systemic Inflammatory Response Syndrome

Treatments: Procedure: cardiac surgery with CPB use

Study type: Observational

Funder types: Other

Identifiers

NCT01020409

MUG grant G-35 (Other Identifier)

N N403 1815 34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 525 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

525 participants in 1 patient group

cardiac surgery with CPB use

Description:

Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.

Treatment:

Procedure: cardiac surgery with CPB use