- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01020409
INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery (INFLACOR)
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Gdańsk, Polen, PL-80-211
- Medical University of Gdańsk, Academic Clinical Centre, Department of Cardiac Anaesthesiology
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
cardiac surgery with CPB use
Adult patients, who signed the informed consent, intervention: first-time scheduled heart 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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
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.
Zeitfenster: between day 2 after operation and hospital discharge
|
between day 2 after operation and hospital discharge
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
all cause inhospital mortality
Zeitfenster: from day 2 after operation
|
from day 2 after operation
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Romuald Lango, MD, PhD, Medical University of Gdansk
- Studienleiter: Maciej M Kowalik, MD, PhD, Medical University of Gdansk
- Hauptermittler: Jan Rogowski, MD, PhD, Medical University of Gdansk
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- Asimakopoulos G. Mechanisms of the systemic inflammatory response. Perfusion. 1999 Jul;14(4):269-77. doi: 10.1177/026765919901400406.
- 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. doi: 10.1016/s1010-7940(99)00134-7.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- N N403 1815 34
- MUG grant G-35 (Andere Kennung: Medical University of Gdańsk)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Systemisches Entzündungsreaktionssyndrom
-
Arkansas Children's Hospital Research InstituteEunice Kennedy Shriver National Institute of Child Health and Human Development...BeendetSIRS (Systemic Inflammatory Response Syndrome)Vereinigte Staaten
-
University of ArkansasBeendetPädiatrische Patienten mit SIRS (Systemic Inflammatory Response Syndrome)Vereinigte Staaten