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EBM in critically unwell patients

Ami Banerjee
Last edited 6th July 2011

Evidence based medicine (EBM) was undoubtedly one of the major medical advances of the last century. EBM is at its best when it changes daily clinical practice and challenges well-established norms, but this only really happens every now and then. Two recent New England Journal papers about management of critically unwell patients have done just that.

Since medical school, doctors learn that the optimal treatment of patients with severe infection (sepsis) and low blood pressure (shock) is to pour in intravenous fluids. Not something that is up for debate, you would think. There are much more pressing things like drug-eluting stents to take to clinical trials. Well, think again. A paper by Maitland and colleagues reports a trial in Africa where over 3000 children with severe sepsis and shock were randomised to receive either boluses of fluid (albumin and saline) or no bolus in the early stages of treatment. Children with malnutrition or gastroenteritis were excluded. Amazingly, any bolus treatment led to an increase of 45% in the risk of mortality at 48 hours (relative risk 1.45; 95% CI, 1.13 to 1.86; P=0.003). The results were consistent across all subgroups of patients, and now researchers and clinicians all over the world are scratching their heads to understand whether what they have been doing since they were medical students is actually wrong and too much fluid is a bad thing in septic patients.

Intensive care, like surgery, is often cited as a difficult area of medicine for EBM to infiltrate. The traditional mantra is to give ITU patients nutritional support as soon as possible. In a trial of nearly 5000 patients, the two arms were either early initiation of intravenous (also known as parenteral) nutrition on days 1 and 2 of ITU admission, or late initiation of parenteral nutrition after day 7. Late initiation was associated with reduced complications and faster recovery. So EBM is possible in the ITU and it does change practice. What other areas of treatment of the critically unwell do we need to test?

Totally agree

I agree-this research could not have occurred in a developed world setting. The ethical considerations and the situation of being able to do different research in low-income settings will only improve if researchers and populations from those settings are given a voice in the planning of ressearch.

Ethics?

Unfortunately, in order to test our anecdotal practices, we use children in a third world country to establish the evidence for treatment. It's a difficult dilemma; without this study, we wouldn't learn that bolusing is harmful for these medical conditions. But what about the ethics of withholding standard treatment for the research participants, and then continuing the study with 3000 subjects despite learning that treating results in 45% mortality at 48 hours!?!

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