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Notice to hospitals from the Bureau of Drug Surveillance

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Human Albumin therapy in critically ill patients

August 7, 1998

This is to inform you about a publication in the British Medical Journal of July 25, 1998 from the Cochrane Injuries Group (CIG). The article is a review of clinical trials that examined the effects of human albumin on mortality in the critically ill. Please provide this notice to physicians working in your critical care areas.

This type of study is known as meta-analysis. It brings together the findings of some 30 previously published trials examining the effects of albumin in the treatment of seriously ill patients with hypovolaemia and/or hypoalbuminaemia such as those with acute blood loss or burns. Individually, these trials have many limitations especially small sample size, small number of deaths, case mix, resuscitation protocols and differing volume, concentrations and types of fluids used, but considering them together, the authors suggest that such patients given albumin may be less likely to survive their illness than if they are given alternative intravenous therapy. The authors suggest that albumin could be responsible for 6 extra deaths per 100 patients treated. However, it is uncertain whether albumin is responsible for extra deaths or why it might be harmful. Of course, the issue of "best choice" of resuscitation fluid in the critically ill has been controversial for some time and this publication continues the search for the preferred solution to offer the best outcome. The authors encourage the use of well-designed clinical studies to evaluate the effect of albumin as a resuscitation fluid.

At this stage, definitive advice cannot be provided to doctors solely on the basis of the CIG review. The Therapeutic Products Programme is currently reviewing the individual studies which were combined in this meta-analysis. Also, communication with albumin manufacturers is underway to determine what clinical trials are currently ongoing to answer outstanding questions. In addition, safety summaries and Product Monographs from albumin manufacturers are being reviewed. Finally, more clinical trials assessing albumin use in the critically ill have been proposed by manufacturers, in addition to studies already underway. The implications for use of albumin will be considered in light of this evidence as it becomes available.

Meanwhile, it is important that when albumin is to be given, the recommendations in the authorized product information are followed (including indications, contraindications, warnings, precautions, adverse effects and dosage).

This matter has received media coverage and may have lead to patient concern. Patients should be reassured if they have received albumin treatment and recovered from their illness. Information about treatment they have received may be sought from the doctor concerned if patients are worried. If relatives or patients are concerned about the treatment a patient in hospital is now receiving, they may wish to discuss this with the doctor(s) responsible.

If you have any inquiries about this message, you may contact the Continuing Assessment Division, Bureau of Drug Surveillance, Therapeutic Products Programme at (613) 957-0337 or fax (613) 957-0335.