Effects on Microcirculation of IgGAM in Severe Septic/Septic Shock Patients.
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
IgM-enriched immunoglobulins (IgGAM; Pentaglobin ® ) are new therapy for sepsis and septic
shock since they support immune system especially in case of " immunoparalysis" . However
IgGAM isn't commonly prescribed, few centres use it as routine in severe infections and there
aren't any guidelines to determine how and when to use them.
Microcirculatory dysfunction is a crucial aspect in the pathogenesis of sepsis-induced organ
dysfunction, resulting in hypoperfusion and tissue hypoxia. Unpublished clinical data suggest
a beneficial effect of IgGAM at microvascular level proved with near infrared spectroscopy
and Vascular occlusion test (VOT).
This study is a double blind phase II prospective randomised controlled trial that will
include patients admitted to the Intensive Care Unit of the University Hospital "Ospedali
Riuniti" of Ancona, after no more than 24 hours from development of severe sepsis or septic
shoc.
Patients will be randomized into two groups (treaties and controls): patients in group of the
treaties will be submitted to infusion of IgGAM conjugate (Pentaglobin ®) at dosage of 250
mg/kg IV (5 mL/kg) per day (rate of 0.4 mL/kg/h), for 72 hours. The controls will receive
equal amount of physiological NaCl solution (0.9%) as placebo. Neither the patient nor the
staff nurses and MD will be aware of the group and of the treatment applied. IgGAM solutions
or NaCl 0.9% will be provided by the hospital pharmacy in similar bags. The remaining
treatments will not be changed in any way and will be at the discretion of the doctor who's
in charge of the patient. All patients of the two groups will receive the optimal therapy for
their conditions, according to good medical clinical practice (GMP), with appropriate
antibiotic therapy, vasoactive and infusional therapy