Clinical trial NCT01166360: The Usefulness of Growth Differentiation Factor 15 (GDF-15) for Risk Stratification in Cardiac Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Coronary Artery Disease
Keywords: Risk prediction
Euroscore
GDF-15
hsTnT
cardiac surgery
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2010-07-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing primary cardiac surgery at a University hospital.

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.

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 criteria: Inclusion Criteria:

* Patients scheduled for cardiac surgery

Exclusion Criteria:

* Withdrawal of informed consent

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days
Secondary outcomes:
measure: 1 year mortality
timeFrame: 365 days
measure: Renal dysfunction defined according to AKI-criteria
timeFrame: 30 days
measure: MaC score as combined measure of postoperative morbidity
timeFrame: 30 days
measure: Sensitive markers of organ dysfunction
timeFrame: 4 days
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Department of Anesthesiology, University of Luebeck
Study officials:
affiliation: Department of Anesthesiology, University of Luebeck
name: Matthias Heringlake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.