Adjunctive IgM-enriched immunoglobulin therapy with a personalised dose based on serum IgM-titres versus standard dose in the treatment of septic shock: a randomised controlled trial (IgM-fat trial)

Autor: Giacomo Grasselli, Patrizia Murino, Emanuela Biagioni, Martina Tosi, Giorgio Berlot, Giacomo Castiglione, Alberto Corona, Maria Giovanna De Cristofaro, Abele Donati, Paolo Feltracco, Francesco Forfori, Fiorentino Fragranza, Ornella Piazza, Livio Tullo
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: BMJ Open, Vol 11, Iss 2 (2021)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2019-036616
Popis: Introduction In patients with septic shock, low levels of circulating immunoglobulins are common and their kinetics appear to be related to clinical outcome. The pivotal role of immunoglobulins in the host immune response to infection suggests that additional therapy with polyclonal intravenous immunoglobulins may be a promising option in patients with septic shock. Immunoglobulin preparations enriched with the IgM component have largely been used in sepsis, mostly at standard dosages (250 mg/kg per day), regardless of clinical severity and without any dose adjustment based on immunoglobulin serum titres or other biomarkers. We hypothesised that a personalised dose of IgM enriched preparation based on patient IgM titres and aimed to achieve a specific threshold of IgM titre is more effective in decreasing mortality than a standard dose.Methods and analysis The study is designed as a multicentre, interventional, randomised, single-blinded, prospective, investigator sponsored, two-armed study. Patients with septic shock and IgM titres
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