The Usefulness of Growth Differentiation Factor 15 (GDF-15) for Risk Stratification in Cardiac Surgery
|ClinicalTrials.gov Identifier: NCT01166360|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : March 15, 2011
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|
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|
|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|
Patients undergoing cardiac surgery in 2009
Patients undergoing cardiac surgery in 2008
- 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.
- 1 year mortality [ Time Frame: 365 days ]1 year mortality is a more relevant outcome variable than 30 day mortality
- Renal dysfunction defined according to AKI-criteria [ Time Frame: 30 days ]Renal dysfunction is an important outcome variable in cardiac surgery.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166360
|Department of Anesthesiology, University of Luebeck|
|Luebeck, Germany, 23568|
|Principal Investigator:||Matthias Heringlake, MD||Department of Anesthesiology, University of Luebeck|