GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

Inclusion Criteria:

• ≥ 40 weeks corrected gestational age to < 18 years; AND

• Admission to the PICU or CICU; AND

• Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared topre-sepsis baseline) as measured by the modified Proulx criteria; AND

• Documented or suspected infection as the MODS inciting event.

Exclusion Criteria:

• Weight <3kg; OR

• Limitation of care order at the time of screening; OR

• Patients at high likelihood of progression to brain death in opinion of the clinicalteam; OR

• Moribund condition in which the patient is unlikely to survive the next 48 hours inopinion of the clinical team; OR

• History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; OR

• Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophageactivation syndrome; OR

• Peripheral white blood cell count < 1,000 cells/mm3 as the result of myeloablativetherapy OR receipt of myeloablative therapy within the previous 14 days; OR

• Known allergy to GM-CSF; OR

• Known pregnancy; OR

• Lactating females; OR

• Receipt of anakinra or GM-CSF within the previous 28 days; OR

• Resolution of MODS by MODS Day 2; OR

• Previous enrollment in the GRACE-2 study.