RASBU-SEPSIS Study: Effects of rasburicase on renal function during sepsis – a randomized, placebo-controlled, double-blind trial

Condition studied

Patients hospitalised in intensive care, diagnosed with sepsis less than 48 hours ago, uric acid level ≥200µmol/L, adults, negative G6PD deficiency

Investigational medicinal product(s)

Eligibility

Primary endpoint

Worsening of renal function defined by at least one of the following:  The onset of acute kidney injury (AKI) within 7 days of inclusion.  Non-improvement or progression of the stage of AKI according to KDIGO criteria on the 7th day after inclusion

Endpoint detail

Death rate at D28 and D90, The maximum SOFA score during the first 7 days, The evolution of renal aggression markers (N-GAL, Pro-enkephalin, IL-18) in blood and urine at D0, D3, and D7, The evolution of the leukocyte rate, pro- and anti-inflammatory cytokines (TNFα, IL-1, 6, 8, 10) at D1, D3, and D7