Inadvertent Metal Loading of Critically Ill Patients with Acute Renal Failure by Human Albumin Solution Infusion Therapy

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Abstract
Recent reports on the metal contamination of human albumin solutions (HAS) have raised concern about possible medical implications. Large amounts of HAS are infused to premature babies with respiratory distress syndrome, patients with plasmapheresis treatment or acute renal failure. For assessment of the risk of metal loading in patients with acute renal failure, commercially available HAS were analyzed for aluminium, nickel, chromium, manganese, cobalt, zinc, copper, cadmium, lead, and mercury. A considerable contamination of HAS was found for Al, Ni, Cr, Mn, and in part for Co. Additionally, the influence of 3 weeks of daily HAS infusion on metal blood levels was studied in 8 critically ill patients with acute renal failure, protein catabolism, ventilator therapy and hemodialysis treatment. Since most metals are primarily eliminated with the urine, these patients seemed to be at high risk for metal loading. In all patients, a considerable increase in the blood concentrations of Al, Ni, Cr, and in some patients of Mn and Co was found. In addition, the daily dose of Al, Ni, Cr, Mn, and Co by HAS was calculated for the 21st day after start of HAS infusion. In most patients, the dose of Al, Ni, and Cr considerably exceeded (up to a factor of 10) the average daily metal dose absorbed from the diet by healthy subjects. The increase in Mn and Co blood levels, despite a low dose of Mn and Co with the daily HAS infusion, was most likely caused by depletion of Mn and Co tissue stores due to the catabolic state of the patients. The contamination of HAS probably originated from the use of aluminium hydroxyde and from contact of plasma with stainless steel surfaces during the Cohn fractionation process. The high extent of contamination of HAS with Al, Ni and Cr cannot be accepted since it is already technically feasible to produce HAS with metal concentrations comparable to the normal serum level range.