A recent PRAC review has recommended suspension of marketing authorisations for HES solutions for infusion across the EU. Results from drug utilisation studies were reviewed, along with benefit and risk data from clinical trials and observational studies as well as feedback from stakeholders and experts.
Intravenous fluids used for resuscitation of acutely ill patients replace plasma volume and prevent shock following acute blood loss. Intravenous fluids comprise colloid and crystalloid solutions. Colloid solutions increase the relative oncotic pressure of the intravascular space by including molecules that are too large to extravasate, such as starches. Crystalloid solutions are aqueous solutions of salts and other water-soluble molecules, such as saline or Ringer’s solutions. Colloid solutions, including those containing HES, are currently used when treatment with crystalloid solutions alone is not sufficient. Restrictions on the use of HES solutions in critically ill patients and those with sepsis and kidney injury were introduced in 2013 to reduce risk of kidney injury and mortality in these patient populations. These restrictions stated that HES solutions should not be used for more than 24 hours and that patients’ kidney function should be monitored after HES administration.
The PRAC review concluded that the 2013 restrictions have not been sufficiently effective. In view of the serious risks to certain patient populations, the PRAC has recommended suspension of the marketing authorisations for HES solutions and this was considered by the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) 22–25 January, 2018. A position from the CMDh will be adopted and announced in due course.
This press release offers an important update to current fluid management best practice. There are alternative colloids that can be used to replace plasma volume which contain albumin, gelatin or dextran. Visit the Intravenous Fluids section of the Fluid Management Knowledge Centre for more information.
Update: In July 2018 the European Commission took the EU-wide, legally binding decision to continue the marketing of HES under new restrictions. Learn more about these restrictions and how the decision was made with our interactive HES timeline.
Catch-up on the debate surrounding hydroxyethyl starch use as we take you on an interactive journey through its changing fortunes. Do you think current restrictions will be enough to change clinical practice?
This position paper from the Italian Association for the Study of the Liver (AISF) and the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) reviews the evidence for the use of albumin in several settings related to liver cirrhosis.
This paper presents a meta-analysis to determine the impact of resuscitation with albumin on the morbidity and mortality of adult burn patients.
This meta-analysis examines whether the dosing of albumin affects outcomes in type 1 hepatorenal syndrome (HRS).
This review article explores the relationship between low albumin levels and acute kidney injury (AKI).
This meta-analysis pooled data from three large randomised controlled trials to determine whether early goal-directed therapy (EGDT) was an effective intervention for managing septic shock.
This systematic review and meta-analysis looked at the different mortality rates of various intravenous fluids and fluid protocols when used for resuscitation in sepsis.
This Chinese randomised controlled study explores the impact that a goal-directed fluid restriction (GDFR) protocol had on outcomes during anaesthesia for brain surgery.
This review paper examines the role of albumin in chronic liver disease, assessing the evidence for its use in several key clinical areas.
This matched cohort study aimed to determine whether a goal-directed fluid therapy (GDFT) intervention, delivered intraoperatively, would reduce post-operative morbidity in patients undergoing hip revision surgery.
This study explored fluid prescribing practices in intensive care – providing a picture of how fluid resuscitation is being managed internationally.
This multicentre audit reviewed the records of 431 patients who had undergone major elective surgery. The authors sought to determine how well IV fluids were prescribed both intraoperatively and perioperatively when compared with current guidance.
This double-blinded, randomised controlled trial examined whether pre-operative administration of exogenous albumin affected rates of acute kidney injury (AKI).
This article is a review and summary of the current opinion of albumin in fluid management.
This retrospective, observational study used a propensity scoring system to match patients treated with saline with those given a balanced, calcium-free fluid.
Following the European Medicines Agency’s (EMA) suspension of the marketing authorisations of hydroxyethyl starch (HES) solutions across the European Union (EMA, 2018), Roberts et al., have written an open letter addressed to the World Health Organization (WHO) Director General seeking support for the suspension of HES solutions and expanding it to a worldwide ban.
The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) endorse the suspension of hydroxyethyl-starch (HES) solutions, due to serious risks of kidney injury and death in certain patient populations.
The hypothesis that hypertonic fluid has a dual physiological role, increasing circulatory volume while administering minimal volumes and muting the pro-inflammatory response to injury and illness, may be appealing, but is it superior to isotonic fluids in practice?
A recent PRAC review has recommended suspension of marketing authorisations for HES solutions for infusion across the EU.
In this post-hoc, subgroup analysis (study 1) and prospective, single-centre nested cohort (study 2) from the SPLIT (0.9% saline vs. PL-148 for ICU fluid therapy) trial, the investigators hypothesised that patients receiving Plasma-Lyte 148 would require fewer blood products and have less post-operative bleeding than those receiving saline.
Acute kidney injury (AKI) affects one-fifth of major surgery patients, increasing the risk of long-term mortality. This review paper discusses recent study data, discussing the best methods for preventing postoperative AKI.
Guidelines to promote the early recovery of patients undergoing major surgery recommend a restrictive intravenous-fluid strategy for abdominal surgery. However, the supporting evidence is limited, and there is concern about impaired organ perfusion.
Cirrhosis of the liver is a leading cause of mortality. For patients with decompensated cirrhosis, long-term weekly human albumin administration can act as an effective disease-modifying treatment.
In 1896 Ernest Starling published his hypothesis for fluid exchange, whereby fluid exchange exists mainly in the capillaries through a process of plasma ultrafiltration across semipermeable membranes (Starling, 1896). But is this 19th century theory something of the past?
Long-term albumin treatment for ascites associated with cirrhosis has been debated in recent years, with mixed results reported for the treatment’s efficacy. In this non-randomised prospective study, Di Pascoli and colleagues question the benefits of long-term albumin in patients with liver cirrhosis and refractory ascites, focussing on survival and emergent hospitalisations. Could this be part of the solution to the ongoing challenge of ascites in cirrhosis?
The choice of fluid administered during cardiac surgery remains a debated topic, often focussed around colloid solutions containing albumin. Conflicting results from numerous studies have left questions over albumin safety and potential to be superior to crystalloids during surgery. Kingeter et al. hoped to achieve clarity on this controversial topic in a retrospective study of cardiac surgery outcomes over a 12-year period.
Patients admitted to intensive care are often haemodynamically unstable with fluid resuscitation therapy regularly used to overcome this. The use of small volume resuscitation with 20% albumin has historically been limited compared to standard fluid resuscitation with 4–5% albumin due to safety concerns, but could those concerns be misplaced? Read more about how the SWIPE trial has provided new insights into the possibilities of using small volume resuscitation within the ICU.
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