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Randomized Controlled Trial
. 2006 Nov 18;333(7577):1044.
doi: 10.1136/bmj.38985.398704.7C. Epub 2006 Oct 13.

Effect of baseline serum albumin concentration on outcome of resuscitation with albumin or saline in patients in intensive care units: analysis of data from the saline versus albumin fluid evaluation (SAFE) study

SAFE Study Investigators  1 ; Simon Finfer, Rinaldo Bellomo, Suzanne McEvoy, Sing Kai Lo, John Myburgh, Bruce Neal, Robyn Norton
Affiliations
Randomized Controlled Trial

Effect of baseline serum albumin concentration on outcome of resuscitation with albumin or saline in patients in intensive care units: analysis of data from the saline versus albumin fluid evaluation (SAFE) study

SAFE Study Investigators et al. BMJ. .

Abstract

Objective: To determine whether outcomes of resuscitation with albumin or saline in the intensive care unit depend on patients' baseline serum albumin concentration.

Design: Analysis of data from a double blind, randomised controlled trial.

Setting: Intensive care units of 16 hospitals in Australia and New Zealand.

Participants: 6045 participants in the saline versus albumin fluid evaluation (SAFE) study.

Interventions: Fluid resuscitation with 4% albumin or saline in patients with a baseline serum albumin concentration of 25 g/l or less or more than 25 g/l.

Main outcome measures: Primary outcome was all cause mortality at 28 days. Secondary outcomes were length of stay in the intensive care unit, length of stay in hospital, duration of renal replacement therapy, and duration of mechanical ventilation.

Main results: The odds ratios for death for albumin compared with saline for patients with a baseline serum albumin concentration of 25 g/l or less and more than 25 g/l were 0.87 and 1.09, respectively (ratio of odds ratios 0.80, 95% confidence interval 0.63 to 1.02); P=0.08 for heterogeneity. No significant interaction was found between baseline serum albumin concentration as a continuous variable and the effect of albumin and saline on mortality. No consistent interaction was found between baseline serum albumin concentration and treatment effects on length of stay in the intensive care unit, length of hospital stay, duration of renal replacement therapy, or duration of mechanical ventilation.

Conclusion: The outcomes of resuscitation with albumin and saline are similar irrespective of patients' baseline serum albumin concentration.

Trial registration: ISRCTN76588266.

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Conflict of interest statement

Competing interests: The saline versus albumin fluid evaluation study was part funded by CSL. CSL has acted as a sponsor for scientific meetings of the Australian and New Zealand Intensive Care Society and its clinical trials group. CSL has paid travel expenses for Simon Finfer and Rinaldo Bellomo to present the results of the SAFE study at scientific and industry sponsored meetings. Andrew Davies and Diane Stephens own shares in CSL.

Figures

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Fig 1 Effect of fluid resuscitation with albumin or saline on mean serum albumin concentration for seven days after randomisation stratified by baseline serum albumin concentration (≤25 g/l or >25 g/l). Error bars indicate standard deviation
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Fig 2 Unadjusted odds ratio (95% confidence interval) of death in all patients and in subgroups with baseline serum albumin concentration of 25 g/l or less and of more than 25 g/l. (Heterogeneity of treatment effect in subgroups with baseline serum albumin concentration ≤25 g/l v >25 g/l, P=0.08)
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References

    1. Martin GS, Mangialardi RJ, Wheeler AP, Dupont WD, Morris JA, Bernard GR. Albumin and furosemide therapy in hypoproteinemic patients with acute lung injury. Crit Care Med 2002;30:2175-82. - PubMed
    1. Nicholson JP, Wolmarans MR, Park GR. The role of albumin in critical illness. Br J Anaesth 2000;85:599-610. - PubMed
    1. Quinlan GJ, Mumby S, Martin GS, Bernard GR, Gutteridge JM, Evans TW. Albumin influences total plasma antioxidant capacity favorably in patients with acute lung injury. Crit Care Med 2004;32:755-9. - PubMed
    1. Vincent JL, Dubois MJ, Navickis RJ, Wilkes MM. Hypoalbuminemia in acute illness: is there a rationale for intervention? A meta-analysis of cohort studies and controlled trials. Ann Surg 2003;237:319-34. - PMC - PubMed
    1. Goldwasser P, Feldman J. Association of serum albumin and mortality risk. J Clin Epidemiol 1997;50:693-703. - PubMed

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