Plasma Biomarkers in Cardiac Valve Surgery

October 5, 2017 updated by: Jean François Brichant, University of Liege

Measurement of Four Plasma Biomarkers for Risk Stratification and Determination of Functional Recovery After Cardiac Valve Surgery

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • Chu of Liège
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite primary outcome
Time Frame: 30 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU readmission
Time Frame: 30 days
30 days
Post-operative AKI
Time Frame: 48 hours
AKIN stage during the first 48 hours
48 hours
Ejection fraction
Time Frame: 1 year
EF at 30 days and at 1 year
1 year
NYHA
Time Frame: 1 year
NYHA class at 30 days and at 1 year
1 year
MLHFQ
Time Frame: 1 year
Minnesota living with heart failure questionnaire at 30 days and at 1 year
1 year
reshopitalisation
Time Frame: 1 year
hospital admission for cardiac failure during the first postoperative year
1 year
one year mortality
Time Frame: 1 year
mortality during the first postoperative year.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (ESTIMATE)

December 29, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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