Journal Club 18/04/13
“Mortality after fluid bolus in
African children with severe
infection”
Maitland K et al ,N Engl J Med 2011;364:2483-95
Robert Morton
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
Observations
•
•
•
•
•
•
HR 160
BP 95/50
O2 sats 98% in 15L via non re-breathe
Temp 39.5°C
RR 40
BM 5.3
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
?
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.
FEAST trial
• Fluid Expansion as Supportive Therapy
• Population- Children with severe febrile
illness & impaired perfusion
• Intervention- 20-40ml/kg N. saline or
5% albumin solution
• Control- No bolus
• Outcome- Mortality at 48 hrs
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
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)
Results
• Study stopped early due to excess
mortality in the bolus groups.
• 10.6% vs 10.5% vs 7.3%
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?
Are the results valid?
2.
Was the assignment of patients to
treatments randomized?
• Yes
Permuted blocks to achieve 1:1:1 ratio
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
Are the results valid?
4.
Were patients, health workers and study
personnel “blind” to the treatment?
• No
Are the results valid?
5.
Were the groups similar at the start of the
trial?
Yes
Are the results valid?
6.
Aside from the clinical intervention, were
the groups treated equally?
• Yes
What are the results?
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
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)
•
•
•
•
Is cap refill a reliable sign of shock?
Is tachycardia?
Final diagnoses not published
? SIADH- Na levels not reported
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