Immunoglobulin A | Immunoglobulin G | Immunoglobulin M for Septic shock

Inclusion criteria

• {"criterion_text":"- 1. Age > 18 years;\n- 2. Septic shock occurrence < 24 hours; septic shock is identified according to Sepsis-3 definition by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia in patients with sepsis2. Sepsis is defined as a life threatening organ dysfunction identified as an acute change in total SOFA score ≥2 points consequent to the infection;\n- 3. IgM-titers< 60mg/dl (or < 20% of the lower threshold value of local laboratory) within 24 hours from shock occurrence."}

Exclusion criteria

• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- All-cause mortality at day 28.","definition_or_measurement_approach":"Mortality measured at 28 days (all-cause mortality at day 28)."}

Secondary endpoints

• {"endpoint_text":"- All cause mortality at ICU discharge, hospital discharge at day90; - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay; - IFHs day28; - HFD day90; - VFDs day 28; - VasoFDs at day28; - AFDs day28; - ICU acquired weakness at 7, 28 and 90days or hospital discharge defined by MRC Scale; - Occurrence of protocol related adverse events at day28.","definition_or_measurement_approach":"Definitions provided in protocol: ICU free hours (IFHs) at day 28 defined as total number of hours between ICU discharge and day 28 (0 if death occurs in ICU before day 28); Hospital free days (HFDs) at day 90 defined as total number of days between hospital discharge and day 90 (0 if death occurs in hospital before day 90); Ventilation free days (VFDs) at day 28 defined as total number of days patient is alive and free of ventilation between randomisation and day 28 (censored at hospital discharge); Vasopressors free-days (VasoFDs) at day 28 defined analogously for vasopressors; Antibiotic free days (AFDs) at day 28 defined analogously for antibiotic administration; Occurrence of new organ dysfunction defined as SOFA score ≥3 or MOF score ≥1 for the corresponding organ occurring after randomization; ICU acquired weakness assessed by MRC Scale at 7, 28 and 90 days or hospital discharge; mortality endpoints measured at ICU discharge, hospital discharge and day 90; occurrence of protocol-related adverse events recorded at day 28."}

Italy

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

203

Number Of Sites

9

Number Of Participants

356

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"BIOTEST AG","duties_or_roles":"Monetary support","organisation_type":""}