Major questions raised over routine treatment for shock in children

Doctors stunned by results of trial carried out in Africa, which showed excess deaths in children who had been treated by Feast A trial in Africa has raised major questions about the safety of the routine treatment given to children suffering from shock in the UK and other developed countries. It is normal in the UK to inject large amounts of fluid very rapidly into children suffering from shock as a result of, for example, septicaemia (blood poisoning) linked to meningitis. But doctors testing the feasibility of this fast rehydration in Africa have found that more children treated this way died than among those who were not. The outcome of the Fluid Expansion As Supportive Therapy (Feast) trial , funded by the UK’s Medical Research Council , took doctors by surprise and will lead to a rethink of the practice around the world. Fluid resuscitation for shock was introduced in Europe and the US several decades ago without a trial, on the basis that it worked for children in shock who were seriously dehydrated from conditions such as gastroenteritis. Now it appears that the practice may be harmful. The Feast trial was stopped early when the excessive number of deaths became apparent. Scientists are now urging the World Health Organisation, which recommends it, to revisit its guidelines. While it is possible children are more vulnerable in Africa because of malnutrition and the severity of diseases such as malaria, doctors say there is no clear reason why an injection of a large amount of fluid through a 15-minute drip – known as a bolus – would be more dangerous in Africa than in Europe. Children in the trial were getting a high standard of care. It is possible that the potential harm has been masked in rich countries by the availability of ventilators to keep children alive. The trial is the result of 10 years’ work led by Kathryn Maitland, a renowned expert on the use of rehydrating fluids who had hoped to save many children’s lives in Africa by introducing what she had thought was a safe treatment widely used elsewhere. “Emergencies come into hospital all the time,” she said. “Children die within hours of coming into hospital. Doctors feel powerless. To have an intervention that might make a difference would have been very important to them.” The only question in her mind was whether the use of boluses would be safe in an African setting. Some experts argued that it would be unethical to give a bolus to some children but not others in a trial because the treatment was so clearly life-saving. Maitland and everybody involved in the research – as well as those in the critical care community around the world who know the result – were stunned by what they found. Because staff in the six participating hospitals – in Kenya, Uganda and Tanzania – had been trained in caring for very sick children and had been ensured a constant supply of oxygen and drugs, the death rates among the children generally had gone down. Doctors assumed it was because of the boluses. But when the external data monitoring committee looked at the interim results, they told Maitland the trial was being stopped. “It was a very big shock and it took a while to digest,” she said. “I thought it was because we’d done a bad trial, but it wasn’t that. They were very clear that it was a very well-run trial and we had come up with a very important answer.” Feast monitored the care of 3,170 critically ill children in the six hospitals, all of whom had infections such as malaria and septicaemia which lead to fever. These are leading killers of children, causing about two million deaths a year. There was no shortage of cases – the Ugandan hospitals involved admitted 50,000 to 60,000 children a year and so many arrived with shock that doctors were told not to include more than four a day in the trial. Those enrolled, with their parents’ consent, were divided into three groups. Two groups were given emergency boluses of 20 to 40 millilitres of fluid per kilogram of bodyweight – half of them saline and half albumin (derived from blood products) to see whether there was any difference. All the children received the normal treatment in Africa, which is the slow administration of fluids through a drip. The results, published in the New England Journal of Medicine , show survival rates were better than usual. Among those not given a bolus, 92.7% survived. But among the bolus groups, that dropped to 89.4%. That means boluses caused more than three children to die in every hundred treated. Experts believe a trial is now needed in a developed-world setting. “Extrapolating directly from Africa has to be done very carefully,” said Professor Diana Gibb from the MRC clinical trials unit. “Here there is a package of care where kids get fluid and if they really don’t get better, they will go into intensive care and other things will happen including ventilation. “But it is also true that a lot of kids in A&E get boluses of fluid if they look particularly unwell and there might be a diagnosis of sepsis. I suspect because the kids are healthier, it is probably not doing harm but we really don’t know the answer to that.” Dr Jennifer Evans, consultant paediatrician at the University Hospital of Wales in Cardiff, agreed. “At present large numbers of sick children in wealthy countries are routinely given fluid boluses in emergency units and even ambulances before arriving in hospital,” she said. “In the light of the results from Feast it is imperative that we review our current practice and as clinical researchers decide how to evaluate its safety and ask whether it is indeed the best thing to do for our sick children.” Health Africa Medical research Sarah Boseley guardian.co.uk

Posted by on May 26, 2011. Filed under News, Politics, World News. You can follow any responses to this entry through the RSS 2.0. You can skip to the end and leave a response. Pinging is currently not allowed.