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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2009

Last Updated Date

January 8, 2013

Start Date ^ICMJE

October 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01020409 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

INFLACOR - Evaluation of Selected Genetic Polymorphisms, Inflammatory Mediators, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery

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:

anamnestic: recent tooth extractions, chronic inflammatory diseases, specific drug use;
biochemical: C-reacting protein, interleukin-6, tumor necrosing factor alpha;
genetical: single nucleotide polymorphisms of 10 genes associated with inflammatory response; and
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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Systemic Inflammatory Response Syndrome

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: CPB cardiac surgery

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

Intervention: Procedure: cardiac surgery with CPB use

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

525

Completion Date

November 2012

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT01020409

Other Study ID Numbers ^ICMJE

N N403 1815 34, MUG grant G-35

Has Data Monitoring Committee

Yes

Responsible Party

Maciej M. Kowalik, Medical University of Gdansk

Study Sponsor ^ICMJE

Medical University of Gdansk

Collaborators ^ICMJE

Ministry of Science and Higher Education, Poland

Investigators ^ICMJE

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

Information Provided By

Medical University of Gdansk

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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