Human albumin : ICU
Severe sepsis or septic shock After the post hoc analysis on the pre-defined subgroup of patients with severe sepsis enrolled in the SAFE study , many investigators have focused their attention on the potential benefit of human albumin in severe sepsis or septic shock . 19 At the moment , there are at least four different large RCTs ( either completed , planned or ongoing ), which aim at evaluating the possible benefit of albumin administration compared with standard crystalloid infusion in this category of patients ( see Table 1 ). The Early Albumin Resuscitation during Septic Shock – NCT00327704 ( EARSS ) and the Albumin Italian Outcome Sepsis trial – NCT00707122 ( ALBIOS ) trials have been recently completed ( although still unpublished ), whereas the PRECISE
trial has undergone only a pilot phase , pending the publication of the findings observed in the two first trial so as to decide how to proceed . 20 In particular , the EARSS trial is a French multicentre , open-label RCT that enrolled 794 patients with early septic shock randomised to receive either 20 % albumin or normal saline for the first three days of fluid resuscitation , at fixed doses ( 100ml every eight hours ). In contrast , the ALBIOS trial is an Italian multicentre , open-label RCT that planned an enrolment of 1800 patients with severe sepsis from 100 Italian ICUs . Patients have been randomised to receive either 20 % albumin and crystalloids or crystalloids alone during the first phase of volume replacement and targeting , during the next 28 days , serum albumin concentration equal to or greater than 30g / l . 3 Similarly to the EARSS study , the PRECISE trial ( Fluid Resuscitation with 5 % albumin versus Normal Saline in Early Septic Shock ), designed as a Canadian multicentre , double-blind RCT , has planned to enrol 1800 patients with early septic shock , who will be randomised to receive either 5 % albumin or normal saline as fluid challenges during volume resuscitation for a maximal period of 90 days . 20 Lastly , the RASP trial ( Lactated Ringer versus Albumin in Early Sepsis Therapy – NCT01337934 ), which is now recruiting patients , is a Brazilian multicentre , double-blind RCT that planned an enrolment of 360 patients with early severe sepsis , randomised to receive either 4 % albumin or ringer lactate for fluid resuscitation . Thus , in the near future , novel findings will have the possibility of clarifying the potential benefits of albumin administration beyond a safe volume effect in case of hypovolaemia in patients with sepsis syndromes . Moreover , these trials , having both similarities and differences , 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 ),
" Human albumin has a crucial role in regulating the homeostasis of the intravascular blood compartment " and adequate concentration of albumin solutions ( 20 % versus 4 – 5 %).
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 limited . A key limiting factor is the large heterogeneity characterising the population of critically ill . Therefore , a crucial next step will be to characterise the effects of albumin administration in specific categories of patient . As an example , it is now recommended that human albumin should not be employed in patients with traumatic brain injury ; in contrast , patients with severe sepsis or septic shock may benefit from its use . It is very likely that the upcoming novel findings from recently concluded RCTs will better clarify this issue . l
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17 www . hospitalpharmacyeurope . com