HPE Human Albumin Update | Page 4

Introduction

Introduction

This supplement aims to provide an update on the latest developments in the use of resuscitation fluids for volume replacement therapy , including an overview of the use of albumin in this and other clinical settings .
Volume replacement can be required in a range of clinical situations and is normally achieved by the use of crystalloids and / or colloids ( natural and synthetic ). It is generally acknowledged that crystalloids are used for initial treatment for volume replacement . However , in situations where there is a potential for fluid or electrolyte overload , colloids are recommended . Albumin , the only natural colloid , is an effective treatment for volume replacement , and synthetic colloids such as hydroxyethyl starch ( HES ) and gelatin have also been used in the past . However , recent trials and systematic reviews have shown that the use of HES may lead to serious side effects , including impaired renal function and haemostasis , and that use of gelatin may lead to serious adverse events similar to HES , that is , anaphylactoid reactions , acute kidney injury and bleeding . Two large studies ( CHEST and 6S ) demonstrated an increased requirement for renal replacement therapy and even mortality ( in the 6S trial ) in critically-ill patients treated with HES when compared with crystalloids . As a result , medical regulatory bodies in Europe and the US ( EMA and FDA , respectively ) have deemed that HES should no longer be given to critically-ill patients or those with sepsis . The FDA also banned the use in cardiac surgery . The CHEST study also showed that the negative effects of HES also extend to non-intensive care surgical patients . In contrast , results from a recent study ( CRISTAL ) suggest that there are no differences in 28-day mortality rates in patients receiving colloids and crystalloids . However , this does not refute the negative results observed in CHEST , 6S and numerous other studies because weakness in design and conduct of the study makes it a high-risk bias study that does not inform clinical practice .
Furthermore , as CRISTAL was an open-label study running over nine years , comparing a mixture of fluids in both the colloids and crystalloid arms , the interpretation of the results is difficult . Albumin , as a natural colloid with significant oncotic properties , appears to be the treatment of choice for volume replacement when colloids are warranted . Also , as a natural protein , albumin has a variety of non-oncotic properties , which may explain some of its beneficial effects beyond volume replacement observed in patients with liver cirrhosis complications ( for example , large volume paracentesis due to refractory ascites , spontaneous bacterial peritonitis and hepatorenal syndrome ). In addition , albumin has been shown to improve morbidity in intensive care and cardiac surgery .
Uncertainty remains regarding the definite reduction of mortality by albumin in critically-ill patients as a group , possibly because of clinical trials in highly heterogeneous patient populations . However , administration of albumin was associated with greater intravascular volume expansion and a trend towards reduced mortality in patients with severe sepsis or septic shock , while morbidity studies have demonstrated that albumin treatment leads to reduced morbidity and improvement in organ function in hypoalbuminaemic patients . In addition , albumin has not been shown to have any significant effect on blood coagulation , with the exception of haemodilution . This property , together with its significant volume expanding effect , contributes to the suitability of albumin for volume replacement during or after cardiac surgery .
Therefore , it is generally accepted that albumin is the gold standard for volume replacement ; however , concerns remain regarding the comparative cost of albumin versus artificial colloids . These concerns are addressed in this supplement where it is evident that , apart from the cost of the resuscitation fluid , other expenses and outcomes ( for example , morbidity , mortality , length of intensive care unit stay ) should be factored into the final costs .
In sum , based on results of recent trials with artificial colloids and albumin , albumin has been demonstrated to be the safest colloid and morbidity and mortality reductions have been established in some patient populations and indications . l
2 www . hospitalpharmacyeurope . com