The Usefulness of Growth Differentiation Factor 15 (GDF-15) for Risk Stratification in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT01166360
First received: July 20, 2010
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging humoral markers for risk stratification in clinically stable heart failure patients and in patients with stable coronary artery disease. No data are available about the prognostic value of these peptides in relation to mortality and morbidity in patients undergoing cardiac surgery.

Primary objective of the present study is to test the hypothesis, that GDF-15 is superior to a standard preoperative risk score, the additive Euroscore for the prediction of 30 day mortality and postoperative morbidity in patients scheduled for cardiac surgery.

Secondary objectives are to test the predictive value of hsTNT, either alone, or in combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and preoperative cerebral oxygen saturation (ScO2) levels.


Condition
Heart Failure
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Relevance of Cerebral Oxygen Saturation, NTproBNP and Preoperative Creatinine Clearance in Cardiac Surgical Patients; Amendment 4: the Prognostic Relevance of Growth Differentiation Factor 15 (GDF-15) and High Sensitive Troponin-t (hsTnT)

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The predictive accuracy of GDF-15 will be compared with the Euroscore. Since the Euroscore has been calibrated for 30 day mortality, this time frame will be used as primary outcome parameter.


Secondary Outcome Measures:
  • 1 year mortality [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
    1 year mortality is a more relevant outcome variable than 30 day mortality

  • Renal dysfunction defined according to AKI-criteria [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Renal dysfunction is an important outcome variable in cardiac surgery.

  • MaC score as combined measure of postoperative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The MACS is a combined score for postoperative complications: low cardiac output syndrome, need for renal replacement therapy, stroke, reintubation.

  • Sensitive markers of organ dysfunction [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Fatty acid binding protein, neutrophyil gelatinase associated lipocalin are sensitive markers of organ dysfunction and shall be used to give more precise information on organ dysfunction.


Biospecimen Retention:   Samples Without DNA

Plasma and urine samples


Enrollment: 2000
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients 2009
Patients undergoing cardiac surgery in 2009
Patients 2008
Patients undergoing cardiac surgery in 2008

Detailed Description:

The study will be based on 2 patient cohorts, a group of patients studied during an observation period (2009) and a validation cohort of patients studied in 2008. The 2009 cohort (about 800 patients) will be analyzed to determine the predictive value of GDF-15 for predicting mortality and morbidity. The 2008 cohort (about 1200 patients) will be used to validate these findings.

Besides conventional morbidity markers, new sensitive markers of organ dysfunction (FABP, NGAL, sFLT-1, PIGF) will also be tested in the 2009 group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients undergoing primary cardiac surgery at a University hospital.

Criteria

Inclusion Criteria:

  • Patients scheduled for cardiac surgery

Exclusion Criteria:

  • Withdrawal of informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01166360

Locations
Germany
Department of Anesthesiology, University of Luebeck
Luebeck, Germany, 23568
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Matthias Heringlake, MD Department of Anesthesiology, University of Luebeck
  More Information

No publications provided by University of Luebeck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Matthias Heringlake, Department of Anesthesiology, University of Luebeck
ClinicalTrials.gov Identifier: NCT01166360     History of Changes
Other Study ID Numbers: CS_RS_2008-2009 - GDF_TNT
Study First Received: July 20, 2010
Last Updated: March 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Luebeck:
Risk prediction
Euroscore
GDF-15
hsTnT
cardiac surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014