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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508071-36-00
Acronym
APHP191099
Enrollment
240
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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

Interventions

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026