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Major African clinical trial ends early due to high mortality in children

BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d3414 (Published 31 May 2011) Cite this as: BMJ 2011;342:d3414
  1. Nayanah Siva
  1. 1London

A large African trial testing the routine use of rapid fluid bolus resuscitation in children with shock has been stopped early because of the number of deaths in children during the two year study.

Doctors have reacted with surprise at the high mortality seen during the FEAST study (Fluid Expansion as Supportive Therapy) in which 3170 children in shock caused by severe infection were assessed in hospitals in Uganda, Kenya, and Tanzania over two years.

Over the past 20 years the technique of fluid bolus resuscitation has been standard practice in children with shock due to severe infections, such as septicaemia or malaria. The technique is indicated in most international emergency paediatric guidelines including those by the World Health Organization (WHO).

However, the FEAST trial, which was funded by the United Kingdom’s Medical Research Council, had to be stopped early. It was the first randomised clinical trial to test the effectiveness of fluid bolus rehydration in children with shock as a result of severe infection.

The study’s results, which were published last week in the New England Journal of Medicine, go against the recommendations of the World Health Organization and normal practice in developed countries.

The study found that not only was giving boluses to children not effective, it was harmful.

The children in the trial were randomly assigned to emergency boluses of the blood derivative albumin, or saline boluses, or to a control group in which the children were slowly given intravenous maintenance fluids.

The trial was designed to assess 3600 children, but was stopped early because of safety concerns.

Results showed that 89% of children given boluses survived the first 48 hours in hospital, but those children given fluids slowly did better and in this group, 93% of children survived. Overall, 297 children died during the study.

Sarah Kiguli, chief investigator on the study in Uganda, speaking on a YouTube video summarising the trial, said: “The results surprised me because I saw a couple of children improving after getting big amounts of fluids, but I was more surprised because the results were against the current recommendations by the WHO and against the normal practice in wealthy countries and this surprised me absolutely.”

One of the study investigators, Charles Engoru from Soroti Regional Hospital, Uganda, said there were vast differences in the equipment available in hospitals in Africa compared with those in the developed world and questioned whether the same results would be seen in developed countries.

“These doctors have ventilators and other emergency support to keep children alive . . . like most African hospitals, ours doesn’t have such equipment,” he said.

The authors of the study have asked the World Health Organization to reassess its guidelines.

Kathryn Maitland, chief investigator on the FEAST study at Imperial College, London said: “We are therefore going to recommend to the WHO and other policy makers that fluids given by a drip should only be given slowly and to replace that which would be given to a critically ill child.”

The New England Journal of Medicine article is at www.nejm.org/doi/full/10.1056/NEJMoa1101549?query=featured_home.

Notes

Cite this as: BMJ 2011;342:d3414

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