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NOSi increased mortality in Septic Shock

Citation/s:
Lopez A et al. Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: Effect on survival in patients with septic shock. Crit Care Med 2004:32(1);21-30
Lead author's name and fax: Dr A Lopez, Hospital Infanta Cristinam, Badajoz, Spain.

Three-part Clinical Question: Does the use of the nitric oxide synthase inhibitor 546C88, in patients with septic shock, improve 28-day survival?
 

Search Terms: severe sepsis, septic shock, nitric oxide, NOSi, RCT

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

The Study Patients: ICU patients, >18yrs, severe sepsis diagnosed ² then PAOP had to be between 8 and 18mmHg, systemic and pulmonary artery catheters in place.
 

Control group (N = 358; 358 analysed): Same as intervention group. Placebo rather than 546C88
 

Experimental group (N = 439; 439 analysed): If (1) MAP30mins or MAP 3 with dobutamine or dopexamine during study period. Treatment for up to 14 days or when map >100mmHg without pressors.

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 - The trial was stopped early after interim analysis suggested a significant treatment harm effect.
4) Did results get omitted, and why? No
5) Did they suggest areas of further research? No
6) Did they make any recommendations based on the results and were they appropriate? Yes - NOSi should not be used in these patients.
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? 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? NOSi should not be used in patients with Septic Shock
12) Should I audit my current practice because of these results? No

Appraised by: Dr C Cairns. Consultant, Intensive Care, Stirling Royal Infirmary, Livilands, Stirling, FK8 2AU ; Monday, October 18, 2004
Email: Chris.Cairns@btinternet.com

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. Cairns CJS. 2004. Lopez A et al. Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: Effect on survival in patients with septic shock. Crit Care Med 2004:32(1);21-30

Kill or Update By: October 2009 

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