Efficacy and safety of adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. standard dose in patients with septic shock. A multicenter, interventional, randomized, single-blinded, two arms, adaptive study design.

You likely can't join if

• 1. Shock of uncertain diagnosis; 2. Hypersensitivity to IgM Preparation in use or its excipients; 3. Patients receiving intravenous immunoglobulins (e.g. IgG or IgM enriched preparations) for > 6 hours before enrolment; 4. Selective absolute IgA deficiency with antibodies to IgA; 5. Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available; 6. Clinical decision to withhold life-sustaining treatment or “too sick to benefit”; 7. Neutrophil count <1.000/mm3; 8. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition); 9. Patients with a known, chronic kidney dysfunction needing dialysis (creatinine ≥ 3.4 mg/dl or creatinine clearance ≤ 30 ml/min/1.73m2); 10. Body Mass Index (BMI) >40; 11. Participation in other clinical trials on adjunctive therapies for sepsis (during past 3 months); 12. Lack or withdrawal of informed consent.