NCT02963480

Brief Summary

Similar to poly-trauma, acute myocardial infarction, or stroke, the speed and appropriateness of therapy administered in the initial hours after severe sepsis develops are likely to influence outcome. However, the crux of matter is the "early diagnosis" lacking of high sensitive and specific test, in contrary to, for instance, the acute coronary syndrome, where the highly sensitive Troponin T is measured and increased values are fix component of the diagnosis and definition of acute myocardial infarction. Cardiac surgery can initiate a systemic inflammatory response syndrome (SIRS) induced by extrinsic and intrinsic factors, which are associated in the pathogenesis of postoperative complications. SIRS is closely related to sepsis, but in contrast sepsis is induced by infection. This strong inflammatory response induces malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation and increased need of vasopressors. The investigators want to assess the timing dynamic of release of IL-6 apart from established markers like CRP, leukocytes, PCT. Target of this is to estimate the time-scope and -advance of an "IL-6 axis panel" toward the measurement of standard inflammation parameters in inflammatory response to surgical trauma as a pre-figuration of non-infectious SIRS and to search for a eligible "cut-off" of IL-6.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

July 6, 2016

Last Update Submit

February 16, 2018

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Change of IL-6

    Change of IL-6 over the observation period, peak and nadir comparison

    10 days

Secondary Outcomes (2)

  • Change of PCT

    10 days

  • Change of bioelectrical impedance analysis

    10 days

Study Arms (2)

Sepsis

Patients, who developed postoperative sepsis

Procedure: Cardiac Surgery

SIRS

Patients, who developed postoperative SIRS

Procedure: Cardiac Surgery

Interventions

Cardiac SurgeryPROCEDURE
SIRSSepsis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prospective observational cohort study in patients with elective cardiac surgery.

You may not qualify if:

  • Emergency procedures
  • Heart transplantation
  • Elective left ventricular assist device (LVAD) implantation
  • Pulmonary thrombendarterectomy
  • Declined informed consent
  • Chronic renal failure on renal replacement therapy
  • Body mass index \< 18
  • Age \< 18 years
  • Pregnant woman
  • Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS)
  • that has produced leukopenia
  • Receiving anti-leucocyte drugs, immunosuppression or TNF-α Blockers
  • CRP \> 2mg.dl-1
  • Patients receiving postoperative extracorporeal membrane oxygenation (ECMO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (14)

  • Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

    PMID: 23353941BACKGROUND

  • Marshall JC, Reinhart K; International Sepsis Forum. Biomarkers of sepsis. Crit Care Med. 2009 Jul;37(7):2290-8. doi: 10.1097/CCM.0b013e3181a02afc.

    PMID: 19487943BACKGROUND

  • Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. doi: 10.1016/s0735-1097(00)00804-4.

    PMID: 10987628BACKGROUND

  • Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.

    PMID: 27059056BACKGROUND

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

  • Evans BJ, Haskard DO, Finch JR, Hambleton IR, Landis RC, Taylor KM. The inflammatory effect of cardiopulmonary bypass on leukocyte extravasation in vivo. J Thorac Cardiovasc Surg. 2008 May;135(5):999-1006. doi: 10.1016/j.jtcvs.2007.08.071.

    PMID: 18455576BACKGROUND

  • Chalaris A, Garbers C, Rabe B, Rose-John S, Scheller J. The soluble Interleukin 6 receptor: generation and role in inflammation and cancer. Eur J Cell Biol. 2011 Jun-Jul;90(6-7):484-94. doi: 10.1016/j.ejcb.2010.10.007. Epub 2010 Dec 8.

    PMID: 21145125BACKGROUND

  • Wolsk E, Mygind H, Grondahl TS, Pedersen BK, van Hall G. IL-6 selectively stimulates fat metabolism in human skeletal muscle. Am J Physiol Endocrinol Metab. 2010 Nov;299(5):E832-40. doi: 10.1152/ajpendo.00328.2010. Epub 2010 Sep 7.

    PMID: 20823453BACKGROUND

  • Kruttgen A, Rose-John S. Interleukin-6 in sepsis and capillary leakage syndrome. J Interferon Cytokine Res. 2012 Feb;32(2):60-5. doi: 10.1089/jir.2011.0062. Epub 2011 Dec 2.

    PMID: 22136372BACKGROUND

  • Scheller J, Chalaris A, Schmidt-Arras D, Rose-John S. The pro- and anti-inflammatory properties of the cytokine interleukin-6. Biochim Biophys Acta. 2011 May;1813(5):878-88. doi: 10.1016/j.bbamcr.2011.01.034. Epub 2011 Feb 4.

    PMID: 21296109BACKGROUND

  • Jones SA, Scheller J, Rose-John S. Therapeutic strategies for the clinical blockade of IL-6/gp130 signaling. J Clin Invest. 2011 Sep;121(9):3375-83. doi: 10.1172/JCI57158. Epub 2011 Sep 1.

    PMID: 21881215BACKGROUND

  • Rose-John S. IL-6 trans-signaling via the soluble IL-6 receptor: importance for the pro-inflammatory activities of IL-6. Int J Biol Sci. 2012;8(9):1237-47. doi: 10.7150/ijbs.4989. Epub 2012 Oct 24.

    PMID: 23136552BACKGROUND

  • Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993 Feb 27;341(8844):515-8. doi: 10.1016/0140-6736(93)90277-n.

    PMID: 8094770BACKGROUND

  • Wacker C, Prkno A, Brunkhorst FM, Schlattmann P. Procalcitonin as a diagnostic marker for sepsis: a systematic review and meta-analysis. Lancet Infect Dis. 2013 May;13(5):426-35. doi: 10.1016/S1473-3099(12)70323-7. Epub 2013 Feb 1.

    PMID: 23375419BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Martin H Bernardi, MD

    Medical University of Vienna, Dept. of Cardiothoracic and Vascular Anesthesia and Intensive Care

    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

July 6, 2016

First Posted

November 15, 2016

Study Start

October 30, 2016

Primary Completion

January 26, 2018

Study Completion

February 5, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

AU(1)