THRILL: Treat Hyperinflammation in child oncology study - A single arm, historically controlled, open label phase II study on the efficacy and safety of the recombinant interleukin (IL)-1R antagonist anakinra in pediatric cancer patients admitted to the intensive care with sepsis and signs of hyperinflammation

Conditions

Hyperinflammation, Sepsis

Brief summary

The difference in 28-day all-cause mortality between the early anakinra + SoC and historical SoC group.

Detailed description

Adverse events (AEs), as characterized by type, frequency, severity (as graded using CTCAE v5.0), ≥ grade 3 liver enzyme abnormalities (ALT, bilirubin), The cumulative incidence of secondary infections., The difference in cumulative Phoenix-8 organ dysfunction score over three days between the early anakinra + SoC and historical SoC group., The difference in cumulative Phoenix-8 organ dysfunction score over seven days between the early anakinra + SoC and historical SoC group., The difference in ICU mortality between the early anakinra + SoC and historical SoC group., The comparison of the two groups of treatment on: - the number of ventilator-free days at day 28 - the number of vasoactive medication-free days at day 28 - the highest VIS score - the cumulative VIS score over seven days - the requirement of CRRT - the requirement of ECMO, The comparison of the two groups of treatment on ICU LOS.

Related papers

No related papers found yet.

Interventions

DRUGANAKINRA

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The difference in 28-day all-cause mortality between the early anakinra + SoC and historical SoC group.	—

Secondary

Measure	Time frame
Adverse events (AEs), as characterized by type, frequency, severity (as graded using CTCAE v5.0), ≥ grade 3 liver enzyme abnormalities (ALT, bilirubin), The cumulative incidence of secondary infections., The difference in cumulative Phoenix-8 organ dysfunction score over three days between the early anakinra + SoC and historical SoC group., The difference in cumulative Phoenix-8 organ dysfunction score over seven days between the early anakinra + SoC and historical SoC group., The difference in ICU mortality between the early anakinra + SoC and historical SoC group., The comparison of the two groups of treatment on: - the number of ventilator-free days at day 28 - the number of vasoactive medication-free days at day 28 - the highest VIS score - the cumulative VIS score over seven days - the requirement of CRRT - the requirement of ECMO, The comparison of the two groups of treatment on ICU LOS.	—

Measure

Time frame

Adverse events (AEs), as characterized by type, frequency, severity (as graded using CTCAE v5.0), ≥ grade 3 liver enzyme abnormalities (ALT, bilirubin), The cumulative incidence of secondary infections., The difference in cumulative Phoenix-8 organ dysfunction score over three days between the early anakinra + SoC and historical SoC group., The difference in cumulative Phoenix-8 organ dysfunction score over seven days between the early anakinra + SoC and historical SoC group., The difference in ICU mortality between the early anakinra + SoC and historical SoC group., The comparison of the two groups of treatment on: - the number of ventilator-free days at day 28 - the number of vasoactive medication-free days at day 28 - the highest VIS score - the cumulative VIS score over seven days - the requirement of CRRT - the requirement of ECMO, The comparison of the two groups of treatment on ICU LOS.

—

Outcome results

None listed