Much discussion has already taken place in the blogosphere about the FEAST study of fluid resuscitation in septic children. Although a well conducted study, its external validity to Western populations is dubious, particularly in view of the proportion of malaria in the cohorts studied.
In the words of my emergency physician colleague Dr Fiona Rae from Wrexham, UK:
“Interesting. As they say, a completely different population in a resource limited setting so it doesn’t translate to UK practice. Majority of these children had malaria and if I read correctly 32% had Hb < 5g/dl. Also 20-40mls/kg is quite a lot of fluid these days as an initial bolus other than in the sort of severely shocked patients that they seemed to exclude. Their overall mortality also seems to be lower than expected for this population.
If you work in an environment without ITU and a high incidence of malaria then its a useful study. They are not the sort of children I see in my resus room with shock though.”
Nicely put Fi!
You can also read an analysis of this study on Dr G’s blog – where you can find other posts on critical care and emergency medicine.
Background
The role of fluid resuscitation in the treatment of children with shock and life-threatening infections who live in resource-limited settings is not established.
Methods
We randomly assigned children with severe febrile illness and impaired perfusion to receive boluses of 20 to 40 ml of 5% albumin solution (albumin-bolus group) or 0.9% saline solution (saline-bolus group) per kilogram of body weight or no bolus (control group) at the time of admission to a hospital in Uganda, Kenya, or Tanzania (stratum A); children with severe hypotension were randomly assigned to one of the bolus groups only (stratum B). Children with malnutrition or gastroenteritis were excluded. The primary end point was 48-hour mortality; secondary end points included pulmonary edema, increased intracranial pressure, and mortality or neurologic sequelae at 4 weeks.
Results
The data and safety monitoring committee recommended halting recruitment after 3141 of the projected 3600 children in stratum A were enrolled. Malaria status (57% overall) and clinical severity were similar across groups. The 48-hour mortality was 10.6% (111 of 1050 children), 10.5% (110 of 1047 children), and 7.3% (76 of 1044 children) in the albumin-bolus, saline-bolus, and control groups, respectively (relative risk for saline bolus vs. control, 1.44; 95% confidence interval [CI], 1.09 to 1.90; P=0.01; relative risk for albumin bolus vs. saline bolus, 1.01; 95% CI, 0.78 to 1.29; P=0.96; and relative risk for any bolus vs. control, 1.45; 95% CI, 1.13 to 1.86; P=0.003). The 4-week mortality was 12.2%, 12.0%, and 8.7% in the three groups, respectively (P=0.004 for the comparison of bolus with control). Neurologic sequelae occurred in 2.2%, 1.9%, and 2.0% of the children in the respective groups (P=0.92), and pulmonary edema or increased intracranial pressure occurred in 2.6%, 2.2%, and 1.7% (P=0.17), respectively. In stratum B, 69% of the children (9 of 13) in the albumin-bolus group and 56% (9 of 16) in the saline-bolus group died (P=0.45). The results were consistent across centers and across subgroups according to the severity of shock and status with respect to malaria, coma, sepsis, acidosis, and severe anemia.
Conclusions
Fluid boluses significantly increased 48-hour mortality in critically ill children with impaired perfusion in these resource-limited settings in Africa.
Mortality after Fluid Bolus in African Children with Severe Infection
NEJM May 26, 2011 Full text available