journal club 18/04/13
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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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
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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
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Observations
• HR 160
• BP 95/50
• O2 sats 98% in 15L via non re-breathe
• Temp 39.5°C
• RR 40
• BM 5.3
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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
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?
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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.
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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
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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
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Outcomes
• Primary outcomeMortality at 48hrs
• Secondary outcomesMortality at 4 weeksNeurological sequelae 4 & 24 weeksEpisodes of hypotensive shockAdverse reactions to fluids (PO, ICP,
allergy)
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Results
• Study stopped early due to excess mortality in the bolus groups.
• 10.6% vs 10.5% vs 7.3%
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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?
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Are the results valid?
2.
Was the assignment of patients to treatments randomized?
• Yes
Permuted blocks to achieve 1:1:1 ratio
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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
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Are the results valid?
4.
Were patients, health workers and study personnel “blind” to the treatment?
• No
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Are the results valid?
5.
Were the groups similar at the start of the trial?
Yes
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Are the results valid?
6.
Aside from the clinical intervention, were the groups treated equally?
• Yes
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What are the results?
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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
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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)
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• Is cap refill a reliable sign of shock?
• Is tachycardia?
• Final diagnoses not published
• ? SIADH- Na levels not reported
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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