The George Institute For Global Health
Global
United Kingdom
India
China
Australia

Saline vs. Albumin Fluid Evaluation Study (SAFE)

Project status: 
Archived

A landmark study that changed the way clinical research is conducted in critical care. The SAFE study investigated the effects of fluid resuscitation with 4% human albumin solution or normal saline solution on all cause mortality of intensive care unit patients. The data collected is further being used to highlight areas where patient outcome maybe improved through sub-study analyses.

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

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.