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

NCT01166360 | Completed

• 1 other identifier: CS_RS_2008-2009 - GDF_TNT
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Coronary Artery Disease

Keywords

Risk prediction; Euroscore; GDF-15; hsTnT; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Patients 2009

Patients undergoing cardiac surgery in 2009

Patients 2008

Patients undergoing cardiac surgery in 2008

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients undergoing primary cardiac surgery at a University hospital.

You may qualify if:

• Patients scheduled for cardiac surgery

You may not qualify if:

• Withdrawal of informed consent

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Department of Anesthesiology, University of Luebeck

Lübeck, 23568, Germany

Location

Related Publications (2)

• 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.

  PMID: 27717384 DERIVED

• 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.

  PMID: 23391200 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine samples

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Matthias Heringlake, MD

  Department of Anesthesiology, University of Luebeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 21, 2010
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 15, 2011

Record last verified: 2011-03

Locations

DE (1)