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

November 14, 2016 updated by: Maciej M. Kowalik, Medical University of Gdansk

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, PL-80-211
        • Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults (at least age 18), who signed informed consent, scheduled for elective cardiac surgery with use of cardiopulmonary bypass.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cardiac surgery with CPB use
Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
Procedure: cardiac 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.
Other Names:
  • heart valve surgery
  • open heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: between day 2 after operation and hospital discharge
between day 2 after operation and hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause inhospital mortality
Time Frame: from day 2 after operation
from day 2 after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Collaborators

Ministry of Science and Higher Education, Poland

Investigators

  • Study Chair: Romuald Lango, MD, PhD, Medical University of Gdansk
  • Study Director: Maciej M Kowalik, MD, PhD, Medical University of Gdansk
  • Principal Investigator: Jan Rogowski, MD, PhD, Medical University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N N403 1815 34
  • MUG grant G-35 (Other Identifier: Medical University of Gdańsk)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD can be made available to other researcher upon reasonable request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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