What was the point?
Sepsis is a common presentation in children, more so in poorer countries. Initial resus fluid boluses are standard in the treatment of this condition in richer countries but (according to introduction) less common in poorer countries. There is no definitive answer on the amount of resus fluids that are appropriate
How was it done?
- Open 2 stratum, 3 armed randomised open randomised tria
Stratum A- without severe hypotension
Arm 1- 20mls 0.9 % saline/kg over 1 hour
Arm 2- 20mls albumin/kg over 1 hour
Arm 3- No bolus (control )
Stratum B- Severe hypotension
Same arms but with 40mls/kg bolus
No control group (due to ethical concerns)
Further 20mls/kg given in all groups (except control) if impaired perfusion persisted.
Where and on whom was it done?
- 6 East African hospitals
- Children aged 2 months- 12 years
- Severe febrile ilness
- Impaired consciousness and/or respiratory distress
- And impaired perfusion (cap refill >3 seconds, weak pulse or severe tachycardia)
- Severe malnutrion
- Non-infective shock
What were they testing and what did they compare it to?
Primary End point; 48 hour mortality
Secondary End points; 4 week mortality, neurological squelae, episodes of hypotensive shock, adverse end points e.g pulmonary odema
The numbers that matter
Lower risk of death in control group
Absolute risk difference 3.3 percentile points(10.5% risk in combined bolus group vs 7.3% in no bolus group)
This study does not support rountine use of fluid boluses in severely ill febrile children in the African setting.
Hard end point (death)
Power analsysis for sample size (adjusted due to lower than expected morality)
Intention to treat analsysis used
Very little crossover
Broad inclusion criteria increase real world applicability
Less good things
Very sick cohort (judging by patient characteristics) in very different environment to what I work in.
Incidence of malaria, with a very different pathophysiology to bacterial sepsis, could affect his analysis
Implications and the road forward
Demonstrates the high quality research that can be undertaken in poorer countries and suggest some of the dogma surrounding fluid resus may be misplaced, especially considering the sub-group did not identify any groups that may be of benefit. However, due to this cohort of patients being treated very differential in the environments which I work I cannot personal change my clinical practice.
On a positive note, it does suggest the local standard of care (no initial fluid bolus) is better than importing the rich world treatment mobile. Even in this extreme setting less medicine appears to be better
If you don’t believe me…