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Systemic Inflammatory Response SyndromeINFLACORNCT01020409

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

An observational study of Systemic Inflammatory Response Syndrome, run by Medical University of Gdansk at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Systemic Inflammatory Response Syndrome
What is being tested?
cardiac surgery with CPB use
Type of treatment
Surgery or procedure
How many people
525 participants
Where
1 sitePoland
Study dates
Oct 2009to Nov 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Gdansk, PL-80-211

Other trials in Poland

About this study

Official title: 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.

Read the 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.
Being tested
cardiac surgery with CPB use
Keywords
cardiac surgery, cardiopulmonary bypass, acute lung injury, acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, myocardial infarct, sepsis
Medical subject headings
Systemic Inflammatory Response Syndrome, Acute Lung Injury, Respiratory Distress Syndrome, Acute Kidney Injury, Atrial Fibrillation, Myocardial Infarction, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac surgery with CPB useProcedure or surgery

    Also called heart valve surgery, open heart surgery

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

Study groups in NCT01020409
Study groupRoleWhat they receive
cardiac surgery with CPB useAdult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use.
Receives: Procedure: cardiac surgery with CPB use

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: between day 2 after operation and hospital discharge

Secondary outcomes (1)

  1. all cause inhospital mortality

    Measured: from day 2 after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2011
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
525 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01020409
Sponsor's protocol ID
N N403 1815 34
Other IDs
MUG grant G-35
Acronym
INFLACOR
Status last verified
Nov 2016
First submitted
24 Nov 2009
Last updated
15 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: IPD can be made available to other researcher upon reasonable request.

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

    PubMed 9728228

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

    PubMed 10456781

  • 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.

    PubMed 1564774

  • 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.

    PubMed 10456395

  • 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.

    PubMed 11888755

  • 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.

    PubMed 1570980

  • 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.

    PubMed 16458214

  • 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.

    PubMed 16820586

  • 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.

    PubMed 14566255

  • 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.

    PubMed 1303622

  • 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.

    PubMed 12682500

  • 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.

    PubMed 17572096

  • 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.

    PubMed 17165018

  • 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.

    PubMed 7509706

  • 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.

    PubMed 1959406

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Inflammatory Response Syndrome, run by Medical University of Gdansk at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01020409, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.

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