Archive for June, 2008|Monthly archive page

Multicentre RCTs evaluating mortality in ICU – Doomed to fail?

Multicentre RCTs evaluating mortality in Intensive Care : Doomed to Fail ? Gustavo A. et al. Crit Care Med, 2008, vol 34, no 4.

The authors performed a systematic search for multicentre RCTs in adult ICU targetting mortality as a primary outcome measure. Perhaps surprisingly they found only 72. Of these, 10 reported a positive effect, 7 negative and 55 neutral.

The authors make some interesting points…

  • of the 10 positive results not all have been implemented, either because of tight inclusion criteria or subsequent neutral/ negative evidence
  • 30% of studies failed to adequately report a power calculation
  • assuming a commonly targeted mortality benefit (10%), they estimate approx 60% of studies would be underpowered at the 90% confidence limit.

So is mortality as unrealistic endpoint in disease states inadequately differentiated (like ARDS or sepsis) ?

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Intensity of Renal Support. NIH ARF Trial Network. NEJM 2008.

Intensity of Renal Support in Critically Ill patients with Acute Kidney Injury. VA/NIH Acute Renal Failure Trial Network. N Engl J Med: May 20, 2008;359.

A copy of this paper is available as a PDF in the file box, or you can click the link above for full text.

Intro : This multicentre, non blinded RCT had 2 arms; High intensity intermittent HD (6/week) or CVVH at 35ml/kg vs low intensity intermittant HD (3/week) or CVVH at 20ml/kg. HD was used if the patient’s were heamodynamically stable (defined by cardiovascular SOFA score <2). 1124 patient’s randomised if ARF + 1 additional organ failure present (CRF excluded). Patients on low intensity treatment were permitted isolated ultra-filtration for volume overload if required . Primary end point was all cause mortality at 60 days.

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