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Intravenous N-acetylcysteine versus Sodium Chloride Hydration for the Prevention of Radiocontrast induced Nephropathy.

 

The Bottom Line : Intravenous N-acetylcysteine reduces the incidence of contrast-induced nephropathy.


Level of evidence: 1+

 

Citation: Baker CS. Wragg A. Kumar S. De Palma R. Baker LR. Knight CJ. A rapid protocol for the prevention of contrast-induced renal dysfunction: the RAPPID study. Journal of the American College of Cardiology. 41(12):2114-8, 2003


Lead author's name : Dr. Christopher S. R. Baker, cbaker@hhnt.org

 

Three-part Clinical Question : In patients with stable renal dysfunction undergoing coronary angiography, does intravenous N-acetylcysteine (NAC)reduce the incidence of radiocontrast-induced nephropathy compared to saline hydration, in patients?

 

Search Terms: Not specified.

 

The Study: Blinded randomised controlled trial with intention-to-treat analysis.

 

The Study Patients: 80 patients with stable renal dysfunction (serum Creatinine >120mcmol/l, or calculated Creatinine clearance < 50ml/min) undergoing coronary angiography.


Control group (N = 39): all analysed. 1ml/kg/hr of Normal saline i.v. for 12 hours pre- and post-procedure.


Experimental group (N 41): all analysed . Rapid infusion of 150mg/kg NAC in 500ml normal saline over 30mins, immediately before the procedure followed by 50mg/kg in 500ml normal saline over 4 hours post procedure.

 

The Evidence:

 

Outcome

Time to Outcome

CER

EER

RRR

ARR

NNT

Contrast-induced Nephropathy

 (serum creatinine rise >25% )

96hrs

21%

5%

76.2%

16%

6.25

95% Confidence Intervals:

6 to 100%

1.3-30%

3 to 76

 

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 6 ‘drop-outs’ who did not have serum creatinine measured at 96h. However, results were analysed on an intention-to-treat.

5.       Did they suggest areas of further research? Yes, to study the effect of lower doses of N-acetylcysteine.

6.       Did they make recommendations based on the results and were they appropriate? “Administration of intravenous NAC should be considered in all patients at risk of RCIN before contrast exposure when time constraints preclude adequate oral prophylaxis. Care must be taken in the treatment of patients with impaired left ventricular function”. This is an appropriate recommendation, but it must be emphasised that rises in serum creatinine are surrogate markers for clinically significant renal failure (such as need for renal replacement therapy).

7.       Is the study relevant to my clinical practice? Yes, 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? Perhaps not; critically ill patients differ from this study sample and have a higher risk of acute renal failure. It is unknown if this intervention would benefit our patients, especially in regard to avoiding renal replacement therapy. There were 8 adverse reactions in the experimental group; the safer option of using sodium bicarbonate would be an efficacious alternative. (See companion CAT)

12.   Should I audit my current practice because of these results? One could audit 96h 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. : Baker CS. Wragg A. Kumar S. De Palma R. Baker LR. Knight CJ. A rapid protocol for the prevention of contrast-induced renal dysfunction: the RAPPID study. Journal of the American College of Cardiology. 41(12):2114-8, 2003

 

Edited for the SICS EBMG by CC,SJM.

 

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