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

NCT01020409 | Completed DMC

• 2 other identifiers: N N403 1815 34MUG grant G-35
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• all cause inhospital mortality

  from day 2 after operation

Study Arms (1)

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

Interventions

cardiac surgery with CPB use PROCEDURE

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

Also known as: heart valve surgery, open heart surgery

cardiac surgery with CPB use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adults (age \>=18)
• given and signed informed consent
• no previous cardiac surgery with opening the pericardium

You may not qualify if:

• previous cardiac surgery with opening the pericardium
• consent refused or not given

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology

Gdansk, PL-80-211, Poland

Location

Related Publications (17)

• 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. doi: 10.1016/0954-6111(93)90024-t.

  PMID: 9728228 BACKGROUND

• Asimakopoulos G. Mechanisms of the systemic inflammatory response. Perfusion. 1999 Jul;14(4):269-77. doi: 10.1177/026765919901400406.

  PMID: 10456781 BACKGROUND

• 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.

  PMID: 1564774 BACKGROUND

• 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. doi: 10.1016/s1010-7940(99)00134-7.

  PMID: 10456395 BACKGROUND

• Kurki TS, Jarvinen 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. doi: 10.1016/s1010-7940(02)00007-6.

  PMID: 11888755 BACKGROUND

• 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. doi: 10.1016/0003-4975(92)91446-g.

  PMID: 1570980 BACKGROUND

• 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. doi: 10.1053/j.jvca.2005.03.026.

  PMID: 16458214 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.105.001032.

  PMID: 16820586 BACKGROUND

• 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. doi: 10.1016/s0022-5223(03)00396-9.

  PMID: 14566255 BACKGROUND

• 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. doi: 10.1378/chest.101.6.1644.

  PMID: 1303622 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000050454.01978.3B.

  PMID: 12682500 BACKGROUND

• 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. doi: 10.1016/j.cyto.2007.04.009. Epub 2007 Jun 14.

  PMID: 17572096 BACKGROUND

• 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. doi: 10.1007/s00134-006-0478-x. Epub 2006 Dec 13.

  PMID: 17165018 BACKGROUND

• 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. doi: 10.1164/ajrccm.149.3.7509706.

  PMID: 7509706 BACKGROUND

• 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. doi: 10.1378/chest.100.6.1619.

  PMID: 1959406 BACKGROUND

• 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. doi: 10.1186/1472-6955-6-3.

  PMID: 17394635 BACKGROUND

• 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. doi: 10.1093/eurheartj/ehm355. No abstract available.

  PMID: 17951287 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, and blood morphologic elements after centrifugation frozen to -75C.

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Acute Lung Injury; Respiratory Distress Syndrome; Acute Kidney Injury; Atrial Fibrillation; Myocardial Infarction; Sepsis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis; Infections

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Romuald Lango, MD, PhD

  Medical University of Gdansk

  STUDY CHAIR

• Maciej M Kowalik, MD, PhD

  Medical University of Gdansk

  STUDY DIRECTOR

• Jan Rogowski, MD, PhD

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2012
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)