1. Maitland K et al ,N Engl J Med 2011;364:2483-95
Journal Club 18/04/13
“Mortality after fluid bolus in African children with severe infection”
Maitland K et al ,N Engl J Med 2011;364:
Robert Morton

2. Clinical scenario
Called to resus to see an 18 month old boy admitted with fever & lethargy.
On arrival, child is very quiet, respiratory distress and agitated.
Cool peripheries and mottled limbs.
Cap refill 3 seconds

3. Observations HR 160 BP 95/50 O2 sats 98% in 15L via non re-breathe
Temp 39.5°C
RR 40
BM 5.3

4. Management (APLS) A B - high flow 02 C - Gain IV/IO access
Take blood for FBC, U/E ,LFTs, culture, clotting, cross match
Give 20ml/kg rapid bolus of crystalloid to all patients except those with signs of heart failure as their primary pathology.
Apart from septic shock, it is uncommon to need more than one or two 20ml/kg boluses of fluid.
In septic shock, the first bolus of fluid may be given as 4.5% Human albumin solution.
Give 80ml/kg 3rd generation cephalosporin

5. ?

7. Background
Due to lack of intensive care facilities in Africa, WHO recommends reserving the practice of fluid resuscitation for children with advanced shock (CR> 3 seconds, weak fast pulse). Therefore most children admitted with shock in Africa receive no specific fluid management.
Study was designed to investigate the practice of early resuscitation with a saline bolus or albumin bolus to improve outcomes.

8. FEAST trial Fluid Expansion as Supportive Therapy
Population- Children with severe febrile illness & impaired perfusion
Intervention ml/kg N. saline or 5% albumin solution
Control- No bolus
Outcome- Mortality at 48 hrs

9. Methods Multi centre RCT (Kenya, Tanzania, Uganda.
Children with septic shock assigned to early intervention with 20ml/kg N. saline or 5% albumin or no bolus.
2 strata, with/ without hypotension

10. Outcomes Primary outcome Mortality at 48hrs Secondary outcomes
Mortality at 4 weeks
Neurological sequelae 4 & 24 weeks
Episodes of hypotensive shock
Adverse reactions to fluids (PO, ICP, allergy)

11. Results
Study stopped early due to excess mortality in the bolus groups.
10.6% vs 10.5% vs 7.3%

12. CASP 1. Did the trial address a clearly focused issue?
Yes- Are 48 hr mortality rates increased in children with septic shock who receive fluid boluses?

13. Are the results valid? 2.
Was the assignment of patients to treatments randomized?
Yes
Permuted blocks to achieve 1:1:1 ratio

14. Are the results valid? 3.
Were all the patients who entered the trial properly accounted for at its conclusion?
Yes
Only 17 (0.5%) children lost to follow up at 48hrs
97, 98 & 98% f/u at 4 weeks

15. Are the results valid? 4.
Were patients, health workers and study personnel “blind” to the treatment? No

16. Are the results valid? 5.
Were the groups similar at the start of the trial?
Yes

18. Are the results valid? 6.
Aside from the clinical intervention, were the groups treated equally?
Yes

19. What are the results?

24. Will the results help locally???
Different population, intensive care facilites available.
Different level of assessment post fluids
Different causes of sepsis, 57% malaria in study (but equal across all groups)-can cause haemodilution and anaemia

25. Criticism of study Impaired perfusion rather than shock studied
Only 26% cap refill > 3 secs
Only 52% 2 signs of shock
Only 67 children (2%) fulfilled WHO criteria for shock (cold hands, weak peripheral pulse and CR >3 seconds)

26. Is cap refill a reliable sign of shock?
Is tachycardia?
Final diagnoses not published
? SIADH- Na levels not reported

27. Further analysis
Further results published in 2013 showed excess mortality from boluses occurred in all subgroups of children.
Mode of death cardiovascular collapse rather than fluid overload