Coronary Artery Bypass
Conditions
Keywords
acute kidney injury, coronary artery bypass, Roxadustat
Brief summary
Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG). Roxadustat is a prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies. This study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.
Detailed description
Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG), with a incidence of 28-38%. Renal ischemia-reperfusion injury is the main mechanism for acute kidney injury after CABG. Roxadustat is a kind of prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies. This study aims to evaluate the efficacy of administration of Roxadustat (before surgery) in the prevention of acute kidney injury after CABG. This is a multicenter, randomized, double-blind, placebo-controlled study.
Interventions
DRUGRoxadustat
orally 100mg every other day for 5-8 days prior to CABG
DRUGPlacebo
orally 100mg every other day for 5-8 days prior to CABG
Sponsors
Beijing Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old * non-emergent CABG and planned cardiopulmonary bypass (CPB) * eGFR\>15ml/min/1.73m2
Exclusion criteria
* pregnancy or breast feeding * malignancy * severe liver dysfunction * acute kidney injury before randomization * uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute kidney injury | 0-48 hours after surgery | elevation of serum creatinine ≥0.3mg/dl（26.5μmol/L）or ≥ 1.5 times baseline levels within 48 hours post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| renal function | 0-3 days after surgery | creatinine, urea, Cystatin-C after surgery |
| new biomarkers of renal injury | immediately after surgery and the first morning after surgery | serum and urine NGAL，urine TIMP2\*IGFBP7 |
| Cardiac Troponin Subunit I (cTnI) | 0-3 days after surgery | peak plasma concentration of cTnI and area under curve (AUC) of cTnI |
| brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) | 0-3 days after surgery | plasma concentration of BNP |
| classification of acute kidney injury | 0-3 days after surgery | classification of of acute kidney injury based on AKIN criteria |
| length of hospital stay and ICU stay | through study completion, an average of one month | length of hospital stay and ICU stay |
| Blood infusion | 0-3 days after surgery | amount of Red blood cells infusion after surgery |
| adverse events | through study completion, an average of one month | adverse events and severe adverse events during hospitalization |
| death | through study completion, an average of one month | death during hospitalization |
Countries
China
Outcome results
None listed