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Plasmapheresis in severe sepsis and septic shock.

Citation/s: Busund R, et al. Plasmapheresis in severe sepsis and septic shock: prospective, randomised, controlled trial. Intensive Care Med (2002) 28:1434-1439.
Lead author's name and fax: Rolf Busund email- rbusund@online.no

Three-part Clinical Question:

 Patients - with severe sepsis and septic shock.

Intervention – Plasmapheresis in addition to standard therapy.

Outcome - 28 day survival (all cause mortality)

Search Terms: Plasmapheresis, Septic shock, Sepsis, Randomised control trial, Outcome.

The Study: Non-blinded randomised controlled trial with intention-to-treat.

The Study Patients: Patients aged 17 to 70 years. Patients had severe sepsis or septic shock. Patients with terminal  underlying disease  were excluded.
 

Control group (N = 52; 52 analysed): Standard therapy. This included antibiotics, fluid resuscitation, surgical procedures;  cardiovascular and ventilatory support when indicated.
 

Experimental group (N = 54; 54 analysed): Plasmapheresis and standard therapy. Plasmapheresis may be beneficial in the removal of toxic mediators and replenishment of deficient proteins. Patients underwent one session of plasmapheresis and a second if clinically indicated. Interestingly, both control and intervention groups underwent systemic heparinisation.

The Evidence:

EBM questions:

1) Do the methods allow accurate testing of the hypothesis? Probably. Plasmapheresis seemed safe (one of the primary aims was to determine safety). However when it comes to determining efficacy there was a significant difference in the ages between the two study groups. This may lead to bias. The control group was older. There was not a significant difference in APACHE III score however – this is age weighted. There were more patients with intra-abdominal infection in the intervention group.

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 authors are suitably guarded. They also point out that when multivariate analysis is performed to correct for age and site of infection that the result is no longer significant (p=0.07)

4) Did results get omitted, and why? No

5) Did they suggest areas of further research? Yes. A larger phase III prospective randomised multi-centre trial was recommended. This would reduced the likelihood  of  different baseline characteristics experienced in this small study. It may be that plasmapheresis augments or reduces the efficacy of activated protein C and this would be worthy of consideration.

6) Did they make any recommendations based on the results and were they appropriate? Yes, that plasmapheresis can be performed safely, and may be of benefit in patients with severe sepsis or septic shock. The authors were correct in not making any general recommendations in light of the unbalanced baseline characteristics

7) Is the study relevant to my clinical practice? Yes

8) What level o f evidence does this study represent? 1^- (RCT with a high risk of bias)

9) What grade of recommendation can I make on this result alone? N/A.

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

11) Should I change my practice because of these results? No not currently.

12) Should I audit my current practice because of these results? Not unless you use plasmapheresis.

Appraised by: V.Ramanathan SHO Anaesthetics FVAH; 15 May 2005
Email: vaidyaram2000@yahoo.com

Kill or Update by: 2010

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. V Ramanathan. 2005 :Busund R, et al. Plasmapheresis in severe sepsis and septic shock: prospective, randomised, controlled trial. Intensive Care Med (2002) 28:1434-1439.

Edited by RJP & CC

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