HPE Human albumin handbook | Page 23

reduction in 90-day mortality compared with those receiving only crystalloids . It was therefore concluded that in patients with severe sepsis , albumin replacement in addition to crystalloids , as compared with crystalloids alone , did not improve the rate of survival at 28 and 90 days , and that the clinical benefit observed in those with septic shock warrants further confirmation .
More recently , based upon previous findings , the efficacy of 4 % albumin administration during the early phase of sepsis was investigated , as compared to lactated Ringer administration , in patients with cancer . 29 After the enrolment of 360 patients , no difference was observed in survival between the two groups at seven days ( 26 % vs . 22 %, p = 0.5 ; primary outcome ), as well as at 28 days , nor in the other secondary outcomes observed .
Further RCTs will allow us to better dissect the effects of albumin , in terms of patient characteristics ( severe sepsis versus septic shock ), adequate timing of treatment ( early versus late ), adequate trigger for albumin administration ( volume versus albumin replacement ), and adequate concentration of albumin solutions ( 20 % versus 4 – 5 %). At the moment , for patients with septic shock , two large RCTs are ongoing : one in Italy ( the ALBIOSS- BALANCED – Albumin Italian Outcome Septic Shock – trial ; NCT03654001 ) and one in Germany ( the Albumin Replacement Therapy in Septic Shock – ARISS – trial ; NCT03869385 ). Their results , which are likely to be available in few years from now , are eagerly anticipated .
and lower net fluid balance ( p < 0.001 ). The total daily amount of administered fluid did not differ significantly between the two groups ( p = 0.10 ). At 28 days , 285 of 895 patients ( 31.8 %) in the albumin group and 288 of 900 ( 32.0 %) in the crystalloid group had died ( relative risk in the albumin group , 1.00 ; 95 % CI 0.87 – 1.14 ; p = 0.94 ). At 90 days , 41.1 % of the albumin group and 43.6 % of the crystalloid group had died ( relative risk , 0.94 ; 95 % CI , 0.85 – 1.05 ; p = 0.29 ). No significant differences in other secondary outcomes were observed between the two groups . Nonetheless , in a post hoc , though not pre-defined , analysis , patients with septic shock receiving albumin administration showed a significant 6.3 % absolute
Conclusions There is a strong biological and physiological rationale on which it is reasonable to hypothesise a potential beneficial effect of human albumin administration in the critically ill . At the same time , the available clinical evidence is still limited . A key limiting factor is the large heterogeneity characterising the population of the critically ill . Therefore , a crucial next step will be to characterise the effects of albumin administration in specific categories of patient . Ongoing research will certainly provide future and interesting insights , which hopefully will further clarify specific and more adequate indications for the use of albumin in critically ill patients .
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