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

Sponsor:	Medical University of Gdansk
Collaborator:	Ministry of Science and Higher Education, Poland
Information provided by:	Medical University of Gdansk
ClinicalTrials.gov Identifier:	NCT01020409

Purpose

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.

Condition	Intervention	Phase
Systemic Inflammatory Response Syndrome	Procedure: cardiac surgery with CPB use	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	INFLACOR - Evaluation of Selected Genetic Polymorphisms, Inflammatory Mediators, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation Help Me Understand Genetics

MedlinePlus related topics: Atrial Fibrillation Heart Attack Heart Surgery Mental Disorders Psychotic Disorders Sepsis

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	525
Study Start Date:	October 2009
Estimated Study Completion Date:	November 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CPB cardiac surgery Adult patients, who signed the informed consent, undergoing first-time scheduled heart surgery with CPB use.	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020409

Locations

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

Sponsors and Collaborators

Medical University of Gdansk

Ministry of Science and Higher Education, Poland

Investigators

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

More Information

Publications:

Butler J, Baigrie RJ, Parker D, Chong JL, Shale DJ, Pillai R, Westaby S, Rocker GM. Systemic inflammatory responses to cardiopulmonary bypass: a pilot study of the effects of pentoxifylline. Respir Med. 1993 May;87(4):285-8.

Asimakopoulos G. Mechanisms of the systemic inflammatory response. Perfusion. 1999 Jul;14(4):269-77. Review.

Higgins TL, Estafanous FG, Loop FD, Beck GJ, Blum JM, Paranandi L. Stratification of morbidity and mortality outcome by preoperative risk factors in coronary artery bypass patients. A clinical severity score. JAMA. 1992 May 6;267(17):2344-8. Erratum in: JAMA 1992 Oct 14;268(14):1860.

Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg. 1999 Jul;16(1):9-13.

Kurki TS, Järvinen O, Kataja MJ, Laurikka J, Tarkka M. Performance of three preoperative risk indices; CABDEAL, EuroSCORE and Cleveland models in a prospective coronary bypass database. Eur J Cardiothorac Surg. 2002 Mar;21(3):406-10.

Butler J, Chong GL, Baigrie RJ, Pillai R, Westaby S, Rocker GM. Cytokine responses to cardiopulmonary bypass with membrane and bubble oxygenation. Ann Thorac Surg. 1992 May;53(5):833-8.

Lamm G, Auer J, Weber T, Berent R, Ng C, Eber B. Postoperative white blood cell count predicts atrial fibrillation after cardiac surgery. J Cardiothorac Vasc Anesth. 2006 Feb;20(1):51-6.

Podgoreanu MV, White WD, Morris RW, Mathew JP, Stafford-Smith M, Welsby IJ, Grocott HP, Milano CA, Newman MF, Schwinn DA; Perioperative Genetics and Safety Outcomes Study (PEGASUS) Investigative Team. Inflammatory gene polymorphisms and risk of postoperative myocardial infarction after cardiac surgery. Circulation. 2006 Jul 4;114(1 Suppl):I275-81.

Gaudino M, Di Castelnuovo A, Zamparelli R, Andreotti F, Burzotta F, Iacoviello L, Glieca F, Alessandrini F, Nasso G, Donati MB, Maseri A, Schiavello R, Possati G. Genetic control of postoperative systemic inflammatory reaction and pulmonary and renal complications after coronary artery surgery. J Thorac Cardiovasc Surg. 2003 Oct;126(4):1107-12.

Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. Review.

Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. Review.

Mitchell JD, Grocott HP, Phillips-Bute B, Mathew JP, Newman MF, Bar-Yosef S. Cytokine secretion after cardiac surgery and its relationship to postoperative fever. Cytokine. 2007 Apr;38(1):37-42. Epub 2007 Jun 14.

Bellomo R, Kellum JA, Ronco C. Defining and classifying acute renal failure: from advocacy to consensus and validation of the RIFLE criteria. Intensive Care Med. 2007 Mar;33(3):409-13. Epub 2006 Dec 13. Review.

Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24. Review.

Knaus WA, Wagner DP, Draper EA, Zimmerman JE, Bergner M, Bastos PG, Sirio CA, Murphy DJ, Lotring T, Damiano A, et al. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest. 1991 Dec;100(6):1619-36.

Gemert van LA, Schuurmans MJ. The Neecham Confusion Scale and the Delirium Observation Screening Scale: capacity to discriminate and ease of use in clinical practice. BMC Nurs. 2007 Mar 29;6:3.

Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Eur Heart J. 2007 Oct;28(20):2525-38. No abstract available.

Responsible Party:	Prof. Romuald Lango, Medical University of Gdańsk, Dept. of Cardiac Anaesthesiology
ClinicalTrials.gov Identifier:	NCT01020409 History of Changes
Other Study ID Numbers:	N N403 1815 34, MUG grant G-35
Study First Received:	November 24, 2009
Last Updated:	July 7, 2011
Health Authority:	Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Gdansk:

cardiac surgery
cardiopulmonary bypass
acute lung injury
acute respiratory distress syndrome
acute kidney injury

atrial fibrillation
postoperative psychosis
myocardial infarct
sepsis

Additional relevant MeSH terms:

Postoperative Complications
Systemic Inflammatory Response Syndrome
Pathologic Processes
Inflammation
Shock

ClinicalTrials.gov processed this record on May 23, 2012