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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01020409

Acronym

INFLACOR

Enrollment

525

Registered

2009-11-25

Start date

2009-10-31

Completion date

2012-11-30

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Inflammatory Response Syndrome

Keywords

cardiac surgery, cardiopulmonary bypass, acute lung injury, acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, myocardial infarct, sepsis

Brief 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.

Interventions

PROCEDUREcardiac surgery with CPB use

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.	between day 2 after operation and hospital discharge

Secondary

Measure	Time frame
all cause inhospital mortality	from day 2 after operation

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 26, 2026