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dc.contributor.authorAlmansa, Raquel
dc.contributor.authorTamayo, Eduardo
dc.contributor.authorAndaluz-Ojeda, David
dc.contributor.authorNogales, Leonor
dc.contributor.authorBlanco, Jesús
dc.contributor.authorEiros, Jose Maria
dc.contributor.authorGomez-Herreras, Jose Ignacio
dc.contributor.authorBermejo-Martin, Jesus F
dc.identifier.citationCrit Care.2015 Feb;(19):90
dc.description.abstractIntravenous immunoglobulins (IVIGs) have not yet demonstrated robust evidence in the benefit for treatment of sepsis. In spite of multiple clinical trials performed with IVIG in sepsis, it remains an experimental therapy for this severe condition. Nonetheless, these trials do not address a number of potential confounding factors, concerning both the patient and the IVIG preparations, which could greatly affect the final result. To name a few, endogenous levels of immunoglobulin isotypes and subclasses are not assessed prior to treatment. The presence/absence of patient antibodies against the microorganism(s) causing sepsis is not evaluated. The accuracy of antibiotic prescription is not included as an adjusting variable. The degree of patient immunosuppression (previous or induced by sepsis) is not documented. In turn, the concentration and antimicrobial specificities of the antibodies contained in the batches of IVIG are not assessed. Neither the pharmacokinetics of IVIG nor its potential immunomodulatory effects are evaluated. In addition, the concept of 'window of opportunity' for IVIG administration following diagnosis of sepsis is not considered. In conclusion, addressing these factors could help to individualise treatment with IVIG for sepsis, which could enhance the opportunities of this drug to show benefits in terms of survival in this severe condition.
dc.subject.meshAnti-Bacterial Agents
dc.subject.meshClinical Trials as Topic
dc.subject.meshImmunoglobulins, Intravenous
dc.subject.meshShock, Septic
dc.titleThe original sins of clinical trials with intravenous immunoglobulins in sepsis.
dc.identifier.journalCritical care (London, England)
dc.pubmedtypeJournal Article
Appears in Collections:Fundaciones e Institutos de Investigación > IIS H. U. Ramón y Cajal > Artículos

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