Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial
Acta Anaesthesiologica Scandinavica,
Год журнала:
2025,
Номер
69(5)
Опубликована: Апрель 3, 2025
Abstract
Background
Sedation
is
often
provided
to
resuscitated
out‐of‐hospital
cardiac
arrest
(OHCA)
patients
tolerate
post‐cardiac
care,
including
temperature
management.
However,
the
evidence
of
benefit
or
harm
from
routinely
administered
deep
sedation
after
limited.
The
aim
this
trial
investigate
effects
continuous
compared
minimal
on
patient‐important
outcomes
in
OHCA
a
large
clinical
trial.
Methods
SED‐CARE
part
2
×
factorial
Sedation,
Temperature
and
Pressure
Cardiac
Arrest
Resuscitation
(STEPCARE)
trial,
randomized
international,
multicentre,
parallel‐group,
investigator‐initiated,
superiority
with
three
simultaneous
intervention
arms.
In
adults
sustained
return
spontaneous
circulation
(ROSC)
who
are
comatose
following
resuscitation
will
be
within
4
hours
(Richmond
agitation
scale
(RASS)
−4/−5)
(
)
(RASS
0
−2)
comparator
),
for
36
h
ROSC.
primary
outcome
all‐cause
mortality
at
6
months
randomization.
two
other
components
STEPCARE
evaluate
control
strategies.
Apart
interventions,
all
aspects
general
intensive
care
according
local
practices
participating
site.
Neurological
prognostication
performed
European
Council
Society
Intensive
Care
Medicine
guidelines
by
physician
blinded
allocation
group.
To
detect
an
absolute
risk
reduction
5.6%
alpha
0.05,
90%
power,
3500
participants
enrolled.
secondary
proportion
poor
functional
randomization,
serious
adverse
events
unit,
patient‐reported
overall
health
status
Conclusion
if
confers
arrest.
Язык: Английский
Fever management with or without a temperature control device after out‐of‐hospital cardiac arrest and resuscitation (TEMP‐CARE): A study protocol for a randomized clinical trial
Acta Anaesthesiologica Scandinavica,
Год журнала:
2025,
Номер
69(5)
Опубликована: Апрель 13, 2025
Fever
is
associated
with
brain
injury
after
cardiac
arrest.
It
unknown
whether
fever
management
a
feedback-controlled
device
impacts
patient-centered
outcomes
in
arrest
patients.
This
trial
aims
to
investigate
or
without
temperature
control
out-of-hospital
The
TEMP-CARE
part
of
the
2
×
factorial
Sedation,
TEmperature
and
Pressure
Cardiac
Arrest
REsuscitation
(STEPCARE)
trial,
randomized,
international,
multicenter,
parallel-group,
investigator-initiated,
superiority
that
will
evaluate
sedation
strategies,
management,
blood
pressure
targets
simultaneously
nontraumatic/nonhemorrhagic
patients
following
hospital
admission.
For
component
described
this
protocol,
be
randomly
allocated
device.
those
managed
device,
if
≥37.8°C
occurs
within
72
h
post-randomization
started
targeting
≤37.5°C.
Standard
treatment,
as
recommended
by
local
guidelines,
including
pharmacological
agents,
provided
participants
both
groups.
two
other
components
STEPCARE
strategies.
Apart
from
interventions,
all
aspects
general
intensive
care
according
practices
participating
site.
A
physician
blinded
intervention
determine
neurological
prognosis
European
Resuscitation
Council
Society
Intensive
Care
Medicine
guidelines.
primary
outcome
all-cause
mortality
at
six
months
post-randomization.
To
detect
5.6%
absolute
risk
reduction
(90%
power,
alpha
.05),
3500
enrolled.
Secondary
include
poor
functional
months,
care-related
serious
adverse
events,
overall
health
status
months.
post-cardiac
affects
patient-important
Язык: Английский
Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP‐CARE): A protocol for a randomized clinical trial
Acta Anaesthesiologica Scandinavica,
Год журнала:
2025,
Номер
69(6)
Опубликована: Май 20, 2025
Abstract
Background
In
patients
resuscitated
after
cardiac
arrest,
a
higher
mean
arterial
pressure
(MAP)
may
increase
cerebral
perfusion
and
attenuate
hypoxic
brain
injury.
Here
we
present
the
protocol
of
arrest
resuscitation
(MAP‐CARE)
trial
aiming
to
investigate
influence
MAP
targets
on
patient
outcomes.
Methods
‐
CARE
is
one
component
Sedation,
Temperature
Pressure
Cardiac
Arrest
Resuscitation
(
STEPCARE
)
2
x
factorial
randomized
trial.
The
an
international,
multicenter,
parallel‐group,
investigator‐initiated,
superiority
designed
test
hypothesis
that
targeting
(>85
mmHg
intervention
versus
lower
(>65
comparator
from
reduces
6‐month
mortality
primary
outcome
).
Trial
participants
are
adults
with
sustained
return
spontaneous
circulation
who
comatose
following
out‐of‐hospital
arrest.
two
other
components
evaluate
sedation
temperature
control
strategies.
Apart
interventions,
all
aspects
general
intensive
care
will
be
according
local
practices
participating
site.
Neurological
prognostication
performed
European
Council
Society
Intensive
Care
Medicine
guidelines
by
physician
blinded
allocation
group.
sample
size
3500
provides
90%
power
alpha
0.05
detect
5.6
absolute
risk
reduction
in
mortality,
assuming
60%
Secondary
outcomes
poor
functional
6
months
randomization,
patient‐reported
overall
health
proportion
predefined
severe
adverse
events.
Conclusion
MAP‐CARE
if
compared
during
mortality.
Язык: Английский