Saline vs. Albumin Fluid Evaluation Study - SAFE

Aims


In patients without brain injury, albumin and saline for fluid resuscitation resulted in similar outcomes at 28 days

To determine the effects on all cause mortality of fluid resuscitation with 4% human albumin solution or normal saline in critically ill patients in intensive care settings.

Methods

Randomised controlled double-blind trial of saline versus albumin fluid in 6,997 patients recruited from intensive care units in Australia and New Zealand.

Status/Results

A paper describing the main findings was published in the New England Journal of Medicine in 2004. A paper describing a detailed analysis of the patients with brain injuries was published in the New England Journal of Medicine in 2007.

In patients in intensive care, 4% human albumin solution or normal saline for fluid resuscitation result in similar outcomes at 28 days. However, a higher death rate was seen in those patients who had traumatic brain injuries who received albumin.

Further manuscripts are in progress.

Publications

The SAFE Study Investigators. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. New Engl J Med 2007;357:874-84.

The SAFE Study Investigators. Finfer S. Bellomo R, McEvoy S, et al. 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 SAFE Study. BMJ 2006;333:1044. Epub 2006 Oct 13.

The SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. New Engl J Med 2004;350:2247-56.

Finfer A, Bellomo R, Myburgh J, Norton R. Efficacy of albumin in critically ill patients. BMJ 2003;326:559-60.

Institute Investigators

Collaboration

Funding Agencies