Renal function after cardiac surgery MedDRA version: 13.1 Level: HLGT Classification code 10011082 Term: Coronary artery disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Retacrit
Product Name: Retacrit
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Sponsors
Skånes Universitetssjukhus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients planed for Coronary Artery Bypass Grafting (CABG). Inclusion criteria: Non-emergent CABG, eGFR-CyC=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Exclusion criteria: Uncontrolled hypertension, pregnancy or fertile woman (less than 50 years old), Epo treatment within 4 weeks, eGFR-CyC<15 or dialysis, known malignancy and Off-pump surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of erythropoietin zeta with brand name Retracrit® given preoperatively in Coronary Artery Bypass Grafting (CABG) patients to attenuate further decrease in renal dysfunction after open heart surgery and it’s safety. Different biological markers for kidney function will be measured postoperatively. ;Secondary Objective: Secondary objectives will be regarding to the study drugs potential effect on brain and heart. These will be evaluated by specific biomarkers. Incidence and nature of AE during the study and the 30 days follow up. ;Primary end point(s): Primary endpoint: Plasma CyC change from day -1 to day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Plasma NGAL, plasma CyC, urinary CyC, eGFR-CyC, plasma creatinine concentration, MDRD eGFR, s-urea, CKMB, Tn I, and S-100 at day 1. During day 2-4, plasma CyC, CyC eGFR, s-creatinine, MDRD eGFR, s-urea and safety aspects as AE and SAE. | — |
Countries
Sweden
Outcome results
None listed