SAFE, TBI, 2007

Web site designed and maintained by Chris Cairns © SICS EBM Group 2004

Is albumin SAFE in Traumatic Brain Injury?

Bottom Line: In critically ill patients with a severe traumatic brain injury, fluid resuscitation with normal saline rather than 4.5% albumin reduces mortality (NNT 8) and improves neurological outcome (NNT 8).

Level of Evidence: 1⁺⁺ (RCT with a very low risk of bias)

Citation/s: Saline or Albumin for fluid resuscitation in patients with traumatic brain injury. The SAFE study Investigators. N Engl J Med 2007;357:874-84.

Lead author's name and email: Dr Myburgh, j.myburgh@unsw.edu.au

Three-part Clinical Question:

Patients: ICU patients with a traumatic brain injury (TBI) in need of fluid resuscitation.

Intervention: Fluid resuscitation with either normal saline or 4.5% albumin.

Outcomes: Functional neurological outcomes at 2 years.

Search Terms: Traumatic brain injury, intensive care, critically ill, resuscitation, saline, albumin.

The Study: Double-blinded, concealed randomised, controlled trial with intention-to-treat.

The Study Patients: Adult intensive care patients with a traumatic brain injury (TBI), in need of fluid resuscitation (post hoc analysis of SAFE study sub group). TBI was defined as trauma plus a GCS of 13 or less at first hospital presentation and an abnormality on CT of the head consistent with TBI. The intervention phase of the trial lasted until death, ICU discharge or 28 days after randomisation. Of the 515 patients enrolled in the study, 40 were lost to follow-up.

Control group (N = 255; 231 analysed): Fluid resuscitation with 4.5% albumin.

Experimental group (N = 260; 229 analysed): Fluid resuscitation with normal saline.

The Evidence (all patients) :

Outcome	Time to Outcome	CER	EER	RRR	ARR	NNT
Death	28 days	26.4%	15.7%	41%	10.7%	9
Death	95% Confidence Intervals:			13-68%	3.3 to18.1%	6-30
Death	24 months	33.2%	20.4%	39%	12.8%	8
Death	95% Confidence Intervals:			13 to 64%	4.4 to 21.2%	5 to 23
Favourable GOSe	24 months	47.3%	60.6%	-28%	-0.133	-8
Favourable GOSe	95% Confidence Intervals:			-49 to -8%	-23 to -3.6 %	-28 to -4

The Evidence - severe TBI (GCS 3-8)

Outcome	Time to Outcome	CER	EER	RRR	ARR	NNT
Death	24 months	41.8%	22.2%	47%	19.6%	5
Death	95% Confidence Intervals:			22 to 72%	9.1 to 30.1%	3 to 11
Favourable outcome	24 months	36.7%	55%	-50%	-18.3%	-5
Favourable outcome	95% Confidence Intervals:			-81 to -19%	-29.8 to -6.8%	-15 to -3

There was no significant difference in outcome in patients with a GCS score of 9-12 (97 patients). Initial ICP tended to be higher in the albumin group.

EBM Comments:

1. Do the methods allow accurate testing of the hypothesis? Yes. Although this was a post hoc analysis it was a large sub group population.

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. “Saline is preferable to albumin during the acute resuscitation of patients with severe traumatic brain injury.”

4. Did results get omitted, and why? Yes. 40 patients lost to follow up.

5. Did they suggest areas of further research? No.

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. Although 4.5% albumin is not the most common colloid used for resuscitation in many centres. Individual clinicians will have to decide whether these results can be extrapolated to other colloid solutions.

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? (i) Yes if you use 4.5% albumin routinely in these patients. (ii) Perhaps, if you use other colloids and are willing to extrapolate these results.

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

Appraised by: Dr Chris Cairns. Consultant, Intensive Care, Stirling Royal Infirmary, UK. September 2007.
Email: Chris.Cairns@fvah.scot.nhs.uk

Kill or Update By: 2013.

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