NCT02727413

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

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

March 23, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 24, 2019

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

March 23, 2016

Last Update Submit

June 21, 2019

Conditions

Infective EndocarditisValvular Heart Disease

Outcome Measures

Primary Outcomes (8)

  • 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 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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (2)

  • Pathogen genotyping

    Before and during intervention at the heart valve

  • Resistance transcripts

    During intervention at the heart valve

Study Arms (2)

Infective endocarditis

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

Procedure: Blood sample collectionOther: Assessment of signs of organ dysfunction

Valvular heart disease

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

Procedure: Blood sample collectionOther: Assessment of signs of organ dysfunction

Interventions

Blood sample collectionPROCEDURE

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

Infective endocarditisValvular heart disease
Assessment of signs of organ dysfunctionOTHER

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

Also known as: SOFA score
Infective endocarditisValvular heart disease

Eligibility Criteria

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

Patients diagnosed with infective endocarditis or valvular heart disease, undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

  • signed informed consent
  • age \> 18
  • confirmed diagnosis of infective endocarditis or valvular heart disease
  • scheduled surgical Intervention with CPB use

You may not qualify if:

  • glucocorticoid dosage above Cushing threshold
  • severe neutropenia (below 1000/mm3)
  • immunosuppression or immunomodulatory therapy
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Studies, Jena University Hospital

Jena, Thuringia, 07747, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32015566DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

EndocarditisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Frank M Brunkhorst, MD

    Jena University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 4, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 24, 2019

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)