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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
98
orally 100mg every other day for 5-8 days prior to CABG
orally 100mg every other day for 5-8 days prior to CABG
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
acute kidney injury
elevation of serum creatinine ≥0.3mg/dl（26.5μmol/L）or ≥ 1.5 times baseline levels within 48 hours post surgery
Time frame: 0-48 hours after surgery
classification of acute kidney injury
classification of of acute kidney injury based on AKIN criteria
Time frame: 0-3 days after surgery
renal function
creatinine, urea, Cystatin-C after surgery
Time frame: 0-3 days after surgery
new biomarkers of renal injury
serum and urine NGAL，urine TIMP2\*IGFBP7
Time frame: immediately after surgery and the first morning after surgery
Cardiac Troponin Subunit I (cTnI)
peak plasma concentration of cTnI and area under curve (AUC) of cTnI
Time frame: 0-3 days after surgery
brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP)
plasma concentration of BNP
Time frame: 0-3 days after surgery
death
death during hospitalization
Time frame: through study completion, an average of one month
length of hospital stay and ICU stay
length of hospital stay and ICU stay
Time frame: through study completion, an average of one month
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Blood infusion
amount of Red blood cells infusion after surgery
Time frame: 0-3 days after surgery
adverse events
adverse events and severe adverse events during hospitalization
Time frame: through study completion, an average of one month