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 - IgM-FAT (Flat Against Titrated)

AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA0 个研究点目标入组 356 人开始时间: 2021年6月18日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•- Age > 18 years;
•- 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 sepsis. Sepsis is defined as a life threatening organ dysfunction identified as an acute change in total SOFA score greater or equal to 2 points consequent to the infection;
•- IgM-titers < 60mg/dl (or < 20% of the lower threshold value of local laboratory) within 24 hours from shock occurrence.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 143
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 213

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

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