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Sodium Bicarbonate versus Sodium Chloride in the Prevention of Radiocontrast-induced Nephropathy.

Citation/s: Merten GJ. Burgess WP. Gray LV. Holleman JH. Roush TS. Kowalchuk GJ. Bersin RM. Van Moore A. Simonton CA 3rd. Rittase RA. Norton HJ. Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 291(19):2328-34, 2004.

Lead author's name & email: Gregory J. Merten tkennedy@carolinas.org

Three-part Clinical Question: Does the use of sodium bicarbonate compared to sodium chloride, reduce the risk of radiocontrast-induced nephropathy in patients with stable renal insufficiency?

Search Terms: Not stated

The Study:Blinded randomised controlled trial without intention-to-treat analysis.

The Study Patients:  patients requiring radiocontrast for angiography, CT or TIPPS with a serum Creatinine of > 97.2mcmol/l and < 707mcmol/l.

Control group (n = 68; 59 analysed): received a total of 9 mMol/kg NaCl around the time of imaging

Experimental group (n = 69; 60 analysed): received 9 mMol/kg NaHCO₃ around the time of imaging

The Evidence:

Comments:

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

4. Did results get omitted? Yes, there were 18 ‘drop-outs’ for various reasons.

Evidence on an intention-to-treat analysis:

5. Did they suggest areas of further research? Yes, that confirmation in a large multi-institutional study would be appropriate.

6. Did they make recommendations based on the results and were they appropriate? Yes, “Hydration with sodium bicarbonate was efficacious and practical,” this is an appropriate recommendation.

7. Is the study relevant to my clinical practice? The patient population was not from intensive care, but given the high risk of acute renal failure in our patients, the findings of the study merit consideration.

8. What level of evidence does this study represent? 1+

9. What grade of recommendation can I make on this result alone? B

10. What grade of recommendation can I make when this study is considered along with other available evidence? B

11. Should I change my practice because of these results? Yes, the intervention is simple, safe and carries potential benefit. However this benefit may not necessarily extend to the prevention of clinically significant renal failure such as need for renal replacement therapy.  The effect in the critically ill may differ.

12. Should I audit my current practice because of these results? One could audit 48h changes in serum creatinine levels before and after this intervention

Appraised by: Nicola S. Ledingham & David Swann. Intensive Care Unit, Royal Infirmary of Edinburgh.

Email: Ledingham30ns@hotmail.com

d.g.swann@ed.ac.uk

Kill or Update By: End 2006

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. Ledingham N, Swann D.. 2004. : Merten GJ. Burgess WP. Gray LV. Holleman JH. Roush TS. Kowalchuk GJ. Bersin RM. Van Moore A. Simonton CA 3rd. Rittase RA. Norton HJ. Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 291(19):2328-34, 2004.

Edited for the SICS EBMG by CC, SJM.

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