Prospective randomized controlled trials: when the gold in the gold standard isn't pure.
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Biomedical subjects
Publications and source records attributed to R L Koretz.
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BACKGROUND: IV albumin has been advocated as adjunctive therapy for hypoalbuminemic patients who are receiving nutrition support. This discussion will critically consider the rationale for this recommendation as well as the evidence available in the medical literature. METHODS: The medical literature was reviewed. RESULTS: Randomized controlled trials have shown that IV albumin improves serum albumin levels. However such therapy does not improve clinical outcome in patients receiving parenteral nutrition. Although no trials exist that test the hypothesis in hypoalbuminemic patients receiving enteral nutrition, the purported "supportive evidence" in the medical literature is actually weak and contradictory. IV albumin does have some associated toxicity, and it is expensive. CONCLUSIONS: There is reason to believe that IV albumin is not effective in improving the clinical outcome of hypoalbuminemic patients who are receiving nutrition support. Until more compelling data become available, it is not reasonable to adopt a policy of routinely correcting the hypoalbuminemia in this way. In fact, hypoalbuminemia may be a manifestation of a serious disease state rather than a marker of deficient protein stores.