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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01166360
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : March 15, 2011
Information provided by:
University of Luebeck

Brief Summary:

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 or disease
Heart Failure Coronary Artery Disease

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.

Study Type : Observational
Actual Enrollment : 2000 participants
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)
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Patients 2009
Patients undergoing cardiac surgery in 2009
Patients 2008
Patients undergoing cardiac surgery in 2008

Primary Outcome Measures :
  1. 30 day mortality [ Time Frame: 30 days ]
    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. 1 year mortality [ Time Frame: 365 days ]
    1 year mortality is a more relevant outcome variable than 30 day mortality

  2. Renal dysfunction defined according to AKI-criteria [ Time Frame: 30 days ]
    Renal dysfunction is an important outcome variable in cardiac surgery.

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

  4. Sensitive markers of organ dysfunction [ Time Frame: 4 days ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients undergoing primary cardiac surgery at a University hospital.

Inclusion Criteria:

  • Patients scheduled for cardiac surgery

Exclusion Criteria:

  • Withdrawal of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01166360

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Matthias Heringlake, Department of Anesthesiology, University of Luebeck Identifier: NCT01166360     History of Changes
Other Study ID Numbers: CS_RS_2008-2009 - GDF_TNT
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011

Keywords provided by University of Luebeck:
Risk prediction
cardiac surgery

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