"Fluid Boluses in African Children with Severe Infection".The New England Journal of Medicine. 2011. 364(26):2483-2495.PubMed•Full text•PDF
Clinical Question
Does fluid bolus resuscitation improve outcomes in African children with severe febrile illness and impaired perfusion?
Bottom Line
Fluid boluses significantly increased mortality at 48 hours in critically ill children with impaired perfusion in resource-limited settings in Africa.
Major Points
Fluid resuscitation is a recommended component of managing children with shock due to severe infections. However, in resource-limited settings, with lack of intensive care facilities, the benefit of fluid bolus resuscitation in children was unclear. This study demonstrated that in severely ill febrile African children, fluid bolus increased the risk of mortality compared to no bolus, challenging widely accepted resuscitation practices in these settings.
Guidelines
As a result of this study, guidelines in resource-limited settings may discourage routine use of bolus fluid resuscitation in febrile children with impaired perfusion absence hypotension. This study may also prompt a review of fluid resuscitation guidelines in other settings.
Design
Multicenter, open, randomized, controlled trial.
N=3,141 children with severe infection and impaired perfusion, excluding malnourished children or those with gastroenteritis.
Stratum A: No severe hypotension, randomized to albumin-bolus group, saline-bolus group, or control group (no bolus).
Stratum B: Severe hypotension, randomized to albumin-bolus group or saline-bolus group.
All children received appropriate antimicrobial treatment, intravenous maintenance fluids, and supportive care.
Population
Inclusion Criteria: Children aged 60 days to 12 years with severe febrile illness, impaired consciousness or respiratory distress, and impaired perfusion.
Exclusion Criteria: Severe malnutrition, gastroenteritis, noninfectious causes of shock, conditions where volume expansion is contraindicated.
Interventions
Albumin bolus (20-40 ml/kg of 5% albumin solution), saline bolus (20-40 ml/kg of 0.9% saline solution), or no bolus.
Outcomes
Primary Outcome: Mortality at 48 hours. Albumin-bolus group (10.6%), saline-bolus group (10.5%), control group (7.3%).
Secondary Outcomes:
- Mortality at 4 weeks, and combined mortality or neurologic sequelae.
- Episodes of suspected pulmonary edema, increased intracranial pressure, hypotensive shock within 48 hours.
- Adverse events related to fluid resuscitation and serious allergic reactions.
Criticisms
- The study excluded malnourished children and those with gastroenteritis, limiting generalizability.
- The trial was conducted without intensive care facilities, which may affect applicability to settings where such resources are available.
Funding
The Medical Research Council, United Kingdom. Baxter Healthcare donated resuscitation fluids.
Further Reading
- Andrews B, Semler MW, Muchemwa L, et al. Effect of an early resuscitation protocol on in-hospital mortality among adults with sepsis and hypotension: a randomized clinical trial. JAMA. 2017;318(13):1233-1240.