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Albumin or saline for fluid resuscitation of the hypoalbuminaemic patient in the ICU?

Citation/s: The SAFE study investigators.  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.  BMJ 2006; 333: 1044-49.

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

Three-part Clinical Question:

Patients: Adult ICU patients with either normal or low baseline serum albumin concentrations requiring fluid resuscitation.

Intervention: Resuscitation with either 4% albumin or 0.9% saline.

Outcomes: Primary: Mortality; Secondary: length of ICU or hospital stay, duration of mechanical ventilation, or duration of renal replacement therapy.

Search Terms: intensive care, saline, albumin, resuscitation, fluid, RCT

The Study:  Double-blinded randomised controlled trial without intention-to-treat. Random assignment of albumin versus saline stratified according to institution and according to diagnosis of trauma.

 

The Study Patients: 16 ICUs.  Age>18.  Exclusions: patients admitted to ICU after treatment of burns, cardiac surgery, and liver transplantation.  In addition to the study fluids patients received enteral nutrition, TPN, blood products, maintenance fluids and specific replacement fluids at the treating physician’s discretion.  Serum albumin concentration at baseline was recorded in all patients.  Hypoalbuminaema was defined as a serum albumin concentration <25g/l.

Control group (N= 3028) 0.9% saline for resuscitation until death, discharge or 28 days after randomization.  Subgroups: baseline serum albumin >25g/l (N= 1805), baseline serum albumin <25g/l (N=1223)
 

Experimental group (N = 3012): 4% albumin for resuscitation until death, discharge or 28 days after randomization. Subgroups: baseline serum albumin >25g/l (N=1784), baseline serum albumin <25g/l (N=1228)

The Evidence:

Baseline serum albumin concentration >25g/l:

Baseline serum albumin concentration <25g/l:

No difference in mortality between saline and albumin fluid resuscitation regardless of baseline serum albumin concentration.  There was an increase in serum albumin concentration in first seven days in patients receiving albumin. There was no difference in length of ICU or hospital stay, duration of mechanical ventilation, or duration of renal replacement therapy.

 EBM questions:

1.      Do the methods allow accurate testing of the hypothesis?  Yes. Large well-conducted study. 

2.      Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes.  Two methods of analysis were used; baseline serum albumin as a binary variable (albumin greater or less than 25g/l) and albumin as a continuous variable.  Both methods showed the same result: there is no difference in outcome between groups regardless of baseline serum albumin concentration.

3.      Are conclusions valid in light of the results?  Yes. Use of either 4% albumin or 0.9% saline for fluid resuscitation in ICU patients results in similar outcomes at 28 days regardless of baseline serum albumin concentration.

4.      Did results get omitted, and why? No

5.      Did they suggest areas of further research?  Yes.  Does an increase in serum albumin in hypoalbuminaemic patient correlate with improved morbidity outcomes? There is no difference in length of ICU or hospital stay, duration of mechanical ventilation, or duration of renal replacement therapy between patients with albumin resuscitation (i.e. increasing albumin concentration) and patients with saline ( i.e. not increasing albumin concentration).

6.      Did they make any recommendations based on the results and were they appropriate?  No.

7.      Is the study relevant to my clinical practice?  Yes, the ICU mortality is lower in this study than in Scottish Intensive Care and there will be differences in case mix between Australia and UK but this study is still applicable to UK practice.

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? This study does not compel you to change your practice as there is no difference in outcome between groups. However, albumin is a more expensive fluid than saline and may be associated with higher complication rates so perhaps consideration should be made to developing local guidelines to avoid albumin use in all comers admitted to ICU (SAFE study results) and specifically in hypoalbuminaemic patients (this study).

12.  Should I audit my current practice because of these results?  Yes. 

 

Appraised by:  Erin Innes; SHO Anaesthetics & Intensive Care, and Brian H Cuthbertson, Consultant in Intensive Care, Aberdeen Royal Infirmary.
Email: erininnes@doctors.org.uk

Kill or Update By: June 2012

Reviewed & edited by CC & BLT.

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. 2007 & JICS 2007 Vol8(2). Innes E, Cuthbertson BH. The SAFE study investigators.  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.  BMJ 2006; 333: 1044-49.

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