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Albumin or Saline?

Citation/s:
The SAFE study investigators, A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004;350:2247-56

Lead author's name and fax: Dr S Finfer at ANZICS. ctg@anzics.com.au

Three-part Clinical Question: Is the use of 4% albumin solution for intravascular resuscitation in intensive care patients associated with a higher mortality when compared with 0.9% saline.
Search Terms: intensive care, resuscitation, fluid, saline, albumin

The Study: Double-blinded concealed randomised controlled trial without intention-to-treat.
The Study Patients: 16 ICUs. Age >18. Patients admitted to the ICU after cardiac surgery, after liver transplantation or after the treatment of burns were excluded. Random assignments stratified according to institution and according to whether there was a diagnosis of trauma or not. In addition to the study fluids patients receives, enteral nutrition, TPN, blood products, maintenance fluids and specific replacement fluids at the discretion of the treating physician.
Control group (N = 3501; 3460 analysed): 0.9% Sodium Chloride solution for intravascular resuscitation until death, discharge or 28 days after randomization.
Experimental group (N = 3499; 3473 analysed): 4% Albumin solution for intravascular resuscitation until death, discharge or 28 days after randomization.

The Evidence:

Comments:
Large well conducted study. No difference in organ failure. Larger volumes administered in the saline group over the first 2 days. More blood administered in the albumin group in the first 2 days. Marginal increase in mortality in trauma patients, with brain injuries, and a decrease in mortality in septic patients, managed with albumin although the study was not designed or powered to determine whether these differences were real.

EBM questions:

1) Do the methods allow accurate testing of the hypothesis? Yes
2) Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes
3) Are conclusions valid in light of the results? Yes “In patients in the ICU, use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days.”
4) Did results get omitted, and why? No
5) Did they suggest areas of further research? Yes. Further study of more selected patient populations.
6) Did they make any recommendations based on the results and were they appropriate? Yes “factors which may influence the choice of resuscitation fluid for the critically ill patient include the individual clinician’s preference, the tolerability of the treatment, its safety, and its cost.”
7) Is the study relevant to my clinical practice? Yes
8) What level of evidence does this study represent? 1⁺⁺
9) What grade of recommendation can I make on this result alone? A

10) What grade of recommendation can I make when this study is considered along with other available evidence? A
11) Should I change my practice because of these results? Possibly, if you have a local policy which favours one of these fluids, your reasons should be reviewed.
12) Should I audit my current practice because of these results? Yes, if currently there is a local policy favouring one of these fluids, it should be reviewed.

Appraised by: Dr Chris Cairns. SICS EBM group. ; Friday, June 04, 2004

Email: Chris.Cairns@btinternet.com

Kill or Update By: June 2008

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