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)
Sponsor study identifier
observational
2,000
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 20, 2010
Actual (reported)July 21, 2010
Actual (reported)December 2010
Actual (reported)December 2010
Actual (reported)30 day mortality
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.
30 days
1 year mortality
365 days
Renal dysfunction defined according to AKI-criteria
30 days
MaC score as combined measure of postoperative morbidity
30 days
Sensitive markers of organ dysfunction
4 days
Patients undergoing cardiac surgery in 2009
Patients undergoing cardiac surgery in 2008
Consecutive patients undergoing primary cardiac surgery at a University hospital.
Department of Anesthesiology, University of Luebeck
Lübeck, 23568, Germany
Heringlake M, Charitos EI, Erber K, Berggreen AE, Heinze H, Paarmann H. Preoperative plasma growth-differentiation factor-15 for prediction of acute kidney injury in patients undergoing cardiac surgery. Crit Care. 2016 Oct 8;20(1):317. doi: 10.1186/s13054-016-1482-3.
Heringlake M, Charitos EI, Gatz N, Kabler JH, Beilharz A, Holz D, Schon J, Paarmann H, Petersen M, Hanke T. Growth differentiation factor 15: a novel risk marker adjunct to the EuroSCORE for risk stratification in cardiac surgery patients. J Am Coll Cardiol. 2013 Feb 12;61(6):672-81. doi: 10.1016/j.jacc.2012.09.059.
Plasma and urine samples
Matthias Heringlake, MD
Department of Anesthesiology, University of Luebeck
2,000 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2010
First Posted
July 21, 2010
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
March 15, 2011
Record last verified: 2011-03
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Source: ClinicalTrials.gov.
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