Authorised Therapeutic confirmatory (Phase III) Patients hospitalised in intensive care, diagnosed with sepsis less than 48 hours ago, uric acid level ≥200µmol/L, adults, negative G6PD deficiency

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

EU CTIS ID: 2023-508071-36-00

What this study is testing

Determine the effect of Rasburicase on the occurrence and evolution of acute renal failure (ARF) in septic patients with uricemia ≥200 µmol/L.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients ≥18 years old
  • Diagnosis of sepsis (presumed or known infection and increase in SOFA score ≥ 2), included within 48 hours of diagnosis.
  • Uricémia ≥ 200 µmol/L
  • Rapid diagnostic test strip for G6PD deficiency negative
  • Patient affiliated with a social security scheme
  • Informed consent form signed

You likely can't join if

  • Minor
  • Other metabolic disorders known to cause hemolytic anemia
  • Chronic treatment with a urate-lowering agent
  • Enrolled in another
  • Sepsis due to urinary obstruction
  • Surgery involving the kidneys or urinary tract in the last 3 months
See the full eligibility criteria
Who can join
  • Patients ≥18 years old
  • Diagnosis of sepsis (presumed or known infection and increase in SOFA score ≥ 2), included within 48 hours of diagnosis.
  • Uricémia ≥ 200 µmol/L
  • Rapid diagnostic test strip for G6PD deficiency negative
  • Patient affiliated with a social security scheme
  • Informed consent form signed
  • Woman of childbearing age using effective contraception throughout the treatment and for 1 month after the end of the treatment.
  • Hospitalised in intensive care unit
What rules you out
  • Minor
  • Other metabolic disorders known to cause hemolytic anemia
  • Chronic treatment with a urate-lowering agent
  • Enrolled in another
  • Sepsis due to urinary obstruction
  • Surgery involving the kidneys or urinary tract in the last 3 months
  • Life expectancy less than 6 months
  • Pregnant or breastfeeding woman
  • Chronic kidney failure on hemodialysis
  • AKI with need for dialysis treatment estimated within 12 hours
  • Known hypersensitivity to Rasburicase, or to any of the excipients,
  • Pre-existing condition or situation at risk of lysis syndrome
  • Known G6PD deficiency or suggestive family history

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.