Rare Diseases Symptoms Automatic Extraction
Home
A random Abstract
Our Project
Our Team
A feasible strategy for preventing blood clots in critically ill patients with acute kidney injury (FBI): study protocol for a randomized controlled trial.
[heparin-induced thrombocytopenia]
Previous
pharmacokinetic
trials
suggested
that
40
mg
subcutaneous
enoxaparin
once
daily
provided
inadequate
thromboprophylaxis
for
intensive
care
unit
patients
.
Critically
ill
patients
with
acute
kidney
injury
are
at
increased
risk
of
venous
thromboembolism
and
yet
are
often
excluded
from
these
trials
.
We
hypothesized
that
for
critically
ill
patients
with
acute
kidney
injury
receiving
continuous
renal
replacement
therapy
,
a
dose
of
1
mg
/
kg
enoxaparin
subcutaneously
once
daily
would
improve
thromboprophylaxis
without
increasing
the
risk
of
bleeding
.
In
addition
,
we
seek
to
utilize
urine
output
prior
to
discontinuing
dialysis
,
and
low
neutrophil
gelatinase-associated
lipocalin
in
dialysis-free
intervals
,
as
markers
of
renal
recovery
.
In
a
multicenter
,
double
-blind
randomized
controlled
trial
in
progress
at
three
intensive
care
units
across
Denmark
,
we
randomly
assign
eligible
critically
ill
adults
with
acute
kidney
injury
into
a
treatment
(
1
mg
/
kg
enoxaparin
subcutaneously
once
daily
)
or
control
arm
(
40
mg
enoxaparin
subcutaneously
once
daily
)
upon
commencement
of
continuous
renal
replacement
therapy
.
We
calculated
that
with
133
patients
in
each
group
,
the
study
would
have
80
%
power
to
show
a
40
%
reduction
in
the
relative
risk
of
venous
thromboembolism
with
1
mg
/
kg
enoxaparin
,
at
a
two
-sided
alpha
level
of
0
.
05
.
An
interim
analysis
will
be
conducted
after
the
first
67
patients
have
been
included
in
each
group
.
Enrolment
began
in
March
2013
,
and
will
continue
for
two
years
.
The
primary
outcome
is
the
occurrence
of
venous
thromboembolism
.
Secondary
outcomes
include
anti-
factor
Xa
activity
,
bleeding
,
heparin-induced
thrombocytopenia
,
filter
lifespan
,
length
of
stay
,
ventilator
free
days
,
and
mortality
.
We
will
also
monitor
neutrophil
gelatinase-associated
lipocalin
and
urine
volume
to
determine
whether
they
can
be
used
as
prognostic
factors
for
renal
recovery
.
Critically
ill
unit
patients
with
acute
kidney
injury
present
a
particular
challenge
in
the
provision
of
thromboprophylaxis
.
This
study
hopes
to
add
to
the
growing
evidence
that
the
existing
recommendation
of
40
mg
enoxaparin
is
inadequate
and
that
1
mg
/
kg
is
both
safe
and
effective
for
thromboprophylaxis
.
In
addition
,
the
study
seeks
to
identify
predictors
of
renal
recovery
allowing
for
the
proper
utilization
of
resources
.
EU
Clinical
Trials
Register
:
EudraCT
number
:
2012
-
004368
-
23
,
25
September
2012
.
Diseases
Validation
Diseases presenting
"secondary outcomes"
symptom
acute rheumatic fever
congenital diaphragmatic hernia
heparin-induced thrombocytopenia
hydrocephalus with stenosis of the aqueduct of sylvius
inclusion body myositis
thoracic outlet syndrome
You can validate or delete this automatically detected symptom
Validate the Symptom
Delete the Symptom