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In the editorial "Treating the wrong children with fluids will cause
harm: response to 'mortality after fluid bolus in African children with
severe infection,'" the expert authors Drs David Southall and Martin
Samuels say: "we are seriously concerned about the conclusions and
implications of the paper."
They continue: "The consequences of responding positively to this
message and not treating hypovolaemic shock with intravenous fluid boluses
could be extremely serious for children in both poorly resourced and
developed countries."
The authors of the editorial cite serious methodological flaws
including the most harmful limitation -- reliance on one non-specific
clinical feature for diagnosing hypovolaemic shock: "we contend that the
study was not specifically treating shock as currently defined by the WHO
(cold hands, capillary refill longer than 3 s and weak, fast pulse).The
clinical features used in this study to define hypovolaemic shock (all
degrees of impaired perfusion) were one or more of the following: severe
tachycardia, a capillary refill time of 3 or more seconds, a lower limb
temperature gradient or a weak radial pulse volume. It was not required
for these signs to be found together, so only one sign could have allowed
inclusion. While these signs are commonly all found in shock, the first
three signs individually have poor specificity for hypovolaemic shock and
thus may be found in other medical conditions. It is their combination,
which is required for confirmation of hypovolaemic shock, that needs rapid
circulatory expansion.
"If this study of seriously ill children, 77% of whom had prostration
or coma, was about shock, we would expect more than the reported 21% of
the cohort to have had poor radial pulse volume. In addition, only 6% were
defined as having 'moderate hypotension'."
The authors of the editorial state: "In our opinion, the study was
inappropriately designed with respect to patient selection and as a result
was probably treating children with serious febrile illnesses due to the
most common of medical problems, namely pneumonia and malaria, but not
hypovolaemic shock. This was because reliance was placed on including
children with clinical signs that individually have poor specificity for
shock."
Furthermore, the authors think that the FEAST trial was actually
harmful to children: "We would argue that treating a large cohort of
children with multiple causes for febrile illness and without confirmation
of 'advanced' hypovolaemic shock would most certainly result in clinical
deterioration if routinely given fluid challenges of 50% of blood volume
in the first 8 hours of treatment."
Therefore, the authors conclude: "The findings of this study must not
lead to changes in practice, until further data with more specific
criteria for shock confirm that fluids should not be administered for
hypovolaemic shock. Until then, existing studies and clinical practice
strongly support the use of bolus fluids to treat hypovolaemic shock as
defined by the WHO in all settings. "
WHO is currently undertaking its own internal review of the FEAST
trial and may organise an expert panel to further investigate the clinical
issues involved in giving fluids to severely ill children.
Competing interests:
One of the authors of the editorial is the medical director of MCAI. I am the executive director
FEAST trial is seriously flawed says Archives editorial
An editorial which criticises the FEAST trial featured in this news
item has just been published in the Archives of Diseases of Childhood
(link to http://adc.bmj.com/content/early/2011/06/28/archdischild-2011-300436.full).
In the editorial "Treating the wrong children with fluids will cause
harm: response to 'mortality after fluid bolus in African children with
severe infection,'" the expert authors Drs David Southall and Martin
Samuels say: "we are seriously concerned about the conclusions and
implications of the paper."
They continue: "The consequences of responding positively to this
message and not treating hypovolaemic shock with intravenous fluid boluses
could be extremely serious for children in both poorly resourced and
developed countries."
The authors of the editorial cite serious methodological flaws
including the most harmful limitation -- reliance on one non-specific
clinical feature for diagnosing hypovolaemic shock: "we contend that the
study was not specifically treating shock as currently defined by the WHO
(cold hands, capillary refill longer than 3 s and weak, fast pulse).The
clinical features used in this study to define hypovolaemic shock (all
degrees of impaired perfusion) were one or more of the following: severe
tachycardia, a capillary refill time of 3 or more seconds, a lower limb
temperature gradient or a weak radial pulse volume. It was not required
for these signs to be found together, so only one sign could have allowed
inclusion. While these signs are commonly all found in shock, the first
three signs individually have poor specificity for hypovolaemic shock and
thus may be found in other medical conditions. It is their combination,
which is required for confirmation of hypovolaemic shock, that needs rapid
circulatory expansion.
"If this study of seriously ill children, 77% of whom had prostration
or coma, was about shock, we would expect more than the reported 21% of
the cohort to have had poor radial pulse volume. In addition, only 6% were
defined as having 'moderate hypotension'."
The authors of the editorial state: "In our opinion, the study was
inappropriately designed with respect to patient selection and as a result
was probably treating children with serious febrile illnesses due to the
most common of medical problems, namely pneumonia and malaria, but not
hypovolaemic shock. This was because reliance was placed on including
children with clinical signs that individually have poor specificity for
shock."
Furthermore, the authors think that the FEAST trial was actually
harmful to children: "We would argue that treating a large cohort of
children with multiple causes for febrile illness and without confirmation
of 'advanced' hypovolaemic shock would most certainly result in clinical
deterioration if routinely given fluid challenges of 50% of blood volume
in the first 8 hours of treatment."
Therefore, the authors conclude: "The findings of this study must not
lead to changes in practice, until further data with more specific
criteria for shock confirm that fluids should not be administered for
hypovolaemic shock. Until then, existing studies and clinical practice
strongly support the use of bolus fluids to treat hypovolaemic shock as
defined by the WHO in all settings. "
WHO is currently undertaking its own internal review of the FEAST
trial and may organise an expert panel to further investigate the clinical
issues involved in giving fluids to severely ill children.
Competing interests: One of the authors of the editorial is the medical director of MCAI. I am the executive director