NCT02641665

Brief Summary

The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

December 22, 2015

Last Update Submit

October 5, 2017

Conditions

Elective Valvular Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Composite primary outcome

    In hospital or 30-days mortality or inotropic support during more than 48 hours or lengthy of ICU stay longer than 5 days

    30 days

Secondary Outcomes (7)

  • ICU readmission

    30 days

  • Post-operative AKI

    48 hours

  • Ejection fraction

    1 year

  • NYHA

    1 year

  • MLHFQ

    1 year

  • +2 more secondary outcomes

Interventions

Cardiac valve surgeryPROCEDURE

Aortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s).

Eligibility Criteria

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

Adult patients undergoing elective or urgent cardiac valve surgery in isolation of in combination with CABG.

You may qualify if:

  • Age ≥ 18 years
  • Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG

You may not qualify if:

  • Emergency or salvage surgery
  • Inability to consent
  • Previous cardiac surgery
  • Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis
  • Active Endocarditis
  • Liver cirrhosis
  • Chronic atrial fibrillation
  • Pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Liege

Liège, 4000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial blood

Central Study Contacts

Gregory A Hans, MD, PhD

CONTACT

+3243667655G.Hans@chu.ulg.ac.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

December 22, 2015

First Posted

December 29, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)