NCT02727413|Completed
Inflammatory Mediator Profiles During Heart Valve Replacement Surgery
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Inflammatory and Vasoactive Mediator Profiles and Pathogen Characterization During Heart Valve Replacement Surgery
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Inflammatory and Vasoactive Mediator Profiles and Pathogen Characterization During Heart Valve Replacement Surgery
Sponsor study identifier
observational
40
1 country
1
Study Start
June 2016
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2016
Actual (reported)April 4, 2016
Actual (reported)June 2016
Actual (reported)February 2017
Actual (reported)February 2017
Actual (reported)Area under the plasma concentration versus time curve (AUC) of Procalcitonin
Plasma levels of Procalcitonin over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of C-reactive Protein (CRP)
Plasma Levels of CRP over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Endothelin 1
Plasma Levels of Endothelin 1 over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Tumor Necrosis Factor (TNF) alpha
Plasma Levels of TNF alpha over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 1beta
Plasma Levels of IL 1beta over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
SOFA Score
24 h before and 24 and 48 h after surgical intervention
Renal replacement therapy
Over 7 days following surgery
Pathogen genotyping
Before and during intervention at the heart valve
Resistance transcripts
During intervention at the heart valve
Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with infective endocarditis in accordance with Duke criteria and scheduled for valve surgery
Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with valvular heart disease, with no signs of infection, scheduled for valve replacement surgery
Drawing of 10 ml blood at inclusion, at the time of CPB connection, 60 min under CPB, at the time of CPB disconnection, 6, 24 and 48 hours post-surgery
Assessment of signs of organ dysfunction based on medical data prior to surgery, 24 and 48 hours post-surgery, and at the time of ICU discharge
Patients diagnosed with infective endocarditis or valvular heart disease, undergoing cardiac surgery with cardiopulmonary bypass
Center for Clinical Studies, Jena University Hospital
Jena, Thuringia, 07747, Germany
Diab M, Tasar R, Sponholz C, Lehmann T, Pletz MW, Bauer M, Brunkhorst FM, Doenst T. Changes in inflammatory and vasoactive mediator profiles during valvular surgery with or without infective endocarditis: A case control pilot study. PLoS One. 2020 Feb 3;15(2):e0228286. doi: 10.1371/journal.pone.0228286. eCollection 2020.
Blood plasma
Frank M Brunkhorst, MD
Jena University Hospital
40 participants (actual enrollment reported by the registry).
First Submitted
March 23, 2016
First Posted
April 4, 2016
Study Start
June 2016
Actual (reported)Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 6
Plasma Levels of IL 6 over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 10
Plasma Levels of IL 10 over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 18
Plasma Levels of IL 18 over time
24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
June 24, 2019
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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