ICU Trials summary

ICU Trials Summary

Study online at quizlet.com/_1myscj
1.

COMMIT Chen2005
Early use of metoprolol in
acute MI

decreased arrhythmias and

reinfarction, but increased
cardiogenic shock especially
during the first day or so after
admission.

2.

DOSE Felker 2011

Furosemide bolus vs.
infusion, low vs. high
dose in decompensated
heart failure

There is no clinical advantage

to a high dose vs. low-dose
furosemide strategy or bolus
vs. continuous infusion
furosemide.

ESCAPE Binanay 2005

Efficacy of PA catheters in
decompensated heart
failure

no mortality or
hospitalization benefit.

4.

IAP-SHOCK II Thiele 2012

lntraaortic balloon
support in ACS with early
revascularization

no improve 30-day mortality

or tissue oxygenation.

5.

MAPPET-3
Konstantinides 2002
Alteplase with or without
heparin for submassive PE

heparin + alteplase
improve stable patients WITH
acute submassive PE

PROTECT PROTECT
Investigators 2011
Dalteparin vs.
unfractionated heparin
for DVT prophylaxis

no differences in clinical
outcome (length of stay,
mortality), but dalteparin
associated with less
pulmonary embolism.

SHOCK Hochman 1999

Early revascularization
versus medical
stabilization in
cardiogenic shock

no improvement 30-day
mortality, but survival benefit
at six months.

8.

TROICA Bottiger 2009

Tenecteplase for OOH
cardiac arrest

NO improvement in
outcome, in comparison with
placebo.

9.

6S Perner 2012 HES vs.

LR for fluid resuscitation
in severe sepsis

hydroxyethyl starch (HES

130/0.42) was associated with
higher 90-day mortality, need
for RRT, and the use of blood
products.

3.

6.

7.

Dr.
Sherif
Badrawy

Digitally signed by Dr.

Sherif Badrawy
DN: cn=Dr. Sherif
Badrawy, o=KKUH,
ou=Critical Care,
email=sherif_badrawy
@yahoo.com, c=SA
Date: 2015.10.22
04:48:18 +03'00'

10.

CHEST
Myburgh 2012
HES vs. saline
for fluid
resuscitation

For ICU patients requiring fluid

resuscitation, hydroxyethyl starch (HES
130/0.4) was equivalent to normal saline
in 90-day mortality, but HES increased
the risk of renal failure and the need for
blood products.

11.

ALBIOS
Caironi 2014
Daily albumin
replacement in
severe sepsis
and septic
shock

did not improve the rate of survival at

28 and 90 days.

12.

ANNANE 2002
Hydrocortisone
therapy for
septic shock

hydrocortisone / fludrocortisone
therapy improved 28-day survival.
Furthermore, steroid therapy reduced
duration of vasopressor therapy & the
risk of death in patients with septic shock
and relative adrenal insufficiency
(regardless of stim test response).

13.

CORTICUS
Sprung 2008
Hydrocortisone
therapy for
septic shock

did not improve outcomes among

patients with septic shock (onset within
72 hours), although it did shorten the
duration of vasopressor dependence.

14.

CRISTAL
Annane2013
Colloids versus
crystalloids for
ICU
hypovolemia

In a heterogeneous ICU population

with hypovolemia, there was no
difference in 28- day mortality
Colloids did demonstrate benefit in
duration of MV, vasopressor use, and 90day mortality

15.

DRAKULOVIC
1999 Semi
recumbent
position for
mechancial
ventilation

reduces frequency and risk of

nosocomial pneumonia, especially in
patients with enteral nutrition.

16.

EPaNIC
Casaer 2011
Early vs. late
TPN

[Late initiation of TPN associated with

faster recovery and fewer
complications, than initiation].

17.

JONES 2010
Lactate
clearance vs.
Scv02 for Early
Goal-Directed
Therapy

lactate clearance is non-inferior to

central venous oxygen saturation for
hospital mortality.

Dr.Sherif Badrawy

ICU Trials summary

18.

PROWESS-SHOCK
Ranieri 2012
Drotrecogin alta
(Xigris) for septic
shock

did not improve 28-day or 90-day

mortality compared to placebo in
patients with septic shock

19.

RIVERS 2001
Early goaldirected therapy
for
severe sepsis and
septic shock

improved resuscitation parameters

and reduced mortality.

ProCESS The
ProCESS
Investigators
2014 EGDT, and
a no-protocol
usual-therapy
approach

all equally effective in treating early

septic shock patients.

SAFE Finfer
2004 Albumin
vs. saline for fluid
resuscitation
For all ICU
patients
requiring fluid
resuscitation,

albumin was equivalent to normal

saline in 28-day mortality .Hypothesisgenerating subgroup analysis indicated
that trauma patients may benefit from
normal saline whereas septic shock
patients may benefit from albumin.

SEPSISPAM
Asfar 2014 High
versus low MAP
goal in septic
shock

a higher MAP goal did not reduce

mortality but did increase the risk of
AF. In a subgroup of patients with Hx of
HTN, a higher MAP reduction in the
need for RRT.

23.

SIC Angstwurm
2007 Selenium
supplementation
in intensive care

not associated with a decrease in

mortality among a heterogeneous ICU
population with SlRS criteria;

24.

SOAPII De
Backer 2010
Dopamine vs
Norepinephrine
for shock
all types of shock

no different in mortality between

norepinephrine and dopamine, except in
pts with cardiogenic shock
Norepinephrine has a mortality benefit,
norepinephrine was more effective as a
vasopressor and was less associated
with arrhythmias.

VASST Russell
2008
Vasopressin vs
additional
norepinephrine
for septic shock

Vasopressin was comparable to

additional norepinephrine among
septic shock patients receiving
norepinephrine.
Vasopressin may provide some
mortality benefit in a subgroup of
patients with less severe vasopressor
requirements.

20.

21.

22.

25.

26.

TRICC Hebert 1999

Restrictive vs.
liberal blood
transfusion in the
ICU

a conservative transfusion
strategy had no impact on
mortality, but did result in a
reduction in RBC transfusions and
fewer cardiac events except
patients with acute MI and unstable
angina

27.

VILLANUEVA 2013
Restrictive vs. liberal
blood transfusion in
upper Gl bleed

a restrictive transfusion strategy

reduced mortality and resulted in
fewer RBC transfusions compared to
a liberal transfusion strategy.

28.

COIITSS COIITSS
Investigators 2010
septic shock
receiving
Hydrocortisone and
intensive insulin Rx

neither intensive glucose control

nor fludrocortisone improved
mortality. Intensive glucose
control was associated with a higher
incidence of hypoglycemia

29.

LEUVEN I van den

Berghe 2002
Intensive insulin
therapy in the SICU

In surgical ICU patients (primarily

cardiac), intensive insulin therapy
reduced ICU mortality, renal
impairment, and bloodstream
infections.

30.

LEUVEN II
Intensive insulin
therapy in the MICU

In medical ICU, intensive insulin

therapy did not improve mortality.
While intensive therapy may have
had a positive effect on duration of
MV and length of ICU stay.

31.

NICE-SUGAR
Intensive insulin
therapy in the
MICU/SICU

Among critically ill patients,

intensive glucose control increased
90-day mortality and the incidence
of severe hypoglycemia compared
to conventional therapy.
a blood glucose target of 180 mg or
less per deciliter resulted in Lower
mortality than did a target of 81 to
108 mg per deciliter.

32.

VISEP Brunkhorst
2008 Intensive
insulin and
pentastarch in
severe sepsis or
septic shock

a very high hypoglycemia rate

without a mortality benefit .
Additionally, pentastarch (HES
200/0.5) causes renal impairment and
may have a dose-dependent
detrimental effect on 90-day
mortality.

33.

ANDIRUILLI 2008
High vs. standarddose PPI for upper Gl
bleeding ulcer and
successful
endoscopic
treatment

a standard-dose IV PPI used

significantly less drug and did not
result in different rebleeding rates
compared to a high-dose infusion.

Dr.Sherif Badrawy

ICU Trials summary

34.

BESSON 1995
Octreotide for
acute variceal
bleeding

sclerotherapy with octreotide is

more effective in reducing rebleeding
rates (but not mortality) compared to
sclerotherapy alone.

42.

PROTRATA
Bouadma 2010
Procalcitonin
algorithm for
guiding antibiotic
therapy

reduced antibiotic exposure but

did not directly improve patient
outcomes.

35.

LAU 2000 PPI

drip for upper Gl
bleeding ulcer

a high-dose omeprazole infusion

reduced recurrent bleeding compared
to placebo following successful
endoscopic treatment.

43.

reduced renal impairment and

mortality compared to placebo.

Therapeutic hypothermia improved

the incidence of favorable discharge
disposition and a trend towards
improved mortality.

SORT 1999
Albumin for
spontaneous
bacterial
peritonitis

BERNARD 2002
*Australian
hypothermia
study
for out-ofhospital arrest*

44.

HACA HACA
Study Group 2002
European
hypothermia
study for out-ofhospital arrest

Therapeutic hypothermia improved

6- month neurologic outcome and
mortality

Wunderink 2003
Linezolid vs
Vancomycin for
HAP

In patients with HAP or VAP,

linezolid was associated with higher
28-day survival compared to
vancomycin in pts with MRSA
pneumonia.

45.

Wunderink 2012
Linezolid vs.
vancomycin for
MRSA HAP

TTM Nielsen
2013
Therapeutic
hypothermia
with 33C versus
36C In patients
with out-ofhospital cardiac
arrest with ROSC

, there was no difference in longterm

mortality between therapeutic
hypothermia with 36C and 33C.

In MRSA pneumonia, linezolid

improves clinical cure rate and cause
less nephrotoxicity than vancomycin,
but it did not improve 60-day
mortality.

46.

de Gans 2002
Dexamethasone
for adult bacterial
meningitis

Early, empiric treatment with

dexamethasone in patients with
suspected meningitis improved
discharge outcome and mortality,
but this effect was only seen with
confirmed S.pneumoniae meningitis.

47.

ABC Awake and

breathing trial

39.

BOZZETTE 1990
Adjunctive
corticosteroids in
patients with
AIDS and
pneumocystis
pneumonia

improved mortality and respiratory

failure among patients with moderateto-severe pneumonia, although steroid
therapy increased the risk of herpes
reactivation and oral thrush.

A sedation awakening trial (SAT)

and a spontaneous breathing trial
(SBT) used together were superior to
SBT alone for reducing duration of
mechanical ventilation and 90-day
mortality. but was associated with
more self extubation, but not more
reintubation following self-extubation.

48.

40.

CHASTER 2003 8
vs. 15 days of
antibiotics for
VAP in late-onset
VAP or earlyonset VAP with
recent antibiotic
exposure

8-days was non-inferior to 15- days

of appropriate antibiotic therapy for
mortality and pneumonia recurrence.

Kress 2000 Daily

interruption of
sedative infusions

Medical ICU patients receiving

continuous infusion sedation with daily
interruption were Weaning from
mechanical ventilation and left the
ICU quicker, NO shorter hospital
course or a mortality benefit.

49.

KUMAR 2006
*Delay in
antibiotics
increases
septic shock
mortality*

antimicrobial administration within

the first hour of documented
hypotension associated with increased
survival to hospital discharge in adult
patients with septic shock. Despite a
progressive increase in mortality rate
with increasing delays,[7.6% increase in
mortality/ hour]

MENDS
Pandharipande
2007
Dexmedetomidine
vs lorazepam in
mechanically
ventilated
patients

dexmedetomidine improved comafree days and time within goal level of

sedation compared to lorazepam, but
required more open-label fentanyl
and had a higher incidence of
bradycardia.

36.

37.

38.

41.

Dr.Sherif Badrawy

ICU Trials summary

50.

SEDCOM Riker
2009
Dexmedetomidine
vs
midazolam

In mechanically ventilated patients,

dexmedetomidine was equivalent to
midazolam in achieving sedation goals,
but reduced ICU delirium and
duration of mechanical ventilation.

51.

PRODEX Jakob
2012
*Dexmedetomidine
vs.
propofol*

In mechanically ventilated patients,

propofol was comparable to
dexmedetomidine with respect to time
within goal sedation, duration of
mechanical ventilation, and ICU length
of stay.

OSCAR Young
2013 HighFrequency
Oscillation for
ARDS

High-frequency oscillation
ventilation in patients with ARDS did
not improve mortality or length of
stay compared to conventional, low
tidal volume MV.

OSCILLATE
Ferguson 2013
High-frequency
oscillation for ARDS

High-frequency oscillation
ventilation in patients with early ARDS
increased mortality compared to
conventional, low tidal volume MV.

SLEAP Mehta 2012

*Light sedation
with and
without daily
interruption*

In mechanically ventilated patients

with a light sedation strategy, daily
interruption of sedation did not
improve patient outcomes. In fact,
interruption was associated with
higher opioid and benzodiazepine
requirements.

STROM 2010
Sedationless MV
A protocol for little
or no sedation
among MV patients

52.

53.

54.

55.

56.

57.

58.

59.

BrackenI Bracken
1984 High dose
methylprednisolone
for acute spinal cord
injury

did not improve neurologic

outcomes compared to low dose
methylprednisolone in patients with
spinal cord injury presenting
within 48 hours. High dose was
associated with more wound
infections.

60.

BrackenII Bracken
1990
Methylprednisolone,
naloxone for acute
spinal cord injury

methylprednisolone improved
motor and sensory function if
initiated within 8 hours of initial
trauma. Patients receiving
methylprednisolone may have more
wound infectionss and Gl bleeding.

61.

CAST CAST
Investigators 1997
Early aspirin use in
acute ischemic
stroke

aspirin within 48 hours reduced

28-day mortality and recurrent
ischemic stroke, although bleeding
events were rare but slightly more
common with aspirin.

62.

CATIS He 2014
BP reduction in
ischemic stroke

ischemic stroke who do not receive

TPA, more aggressive blood pressure
reduction during hospitalization
does not improve mortality or
major disability.

63.

reduced the duration of MV and

ICU length of stay, although it may
increase the incidence of delirium.

DECRA Cooper
2011
Decompressive
craniectomy in
traumatic brain
injury

reduces ICP in patients with

severe TBI without mass lesions,
but does not improve (and may
worsen) functional or unfavorable
outcomes.

64.

Bellomo 2001
ANZICS Dopamine
Renally-dosing
dopamine in early
renal dysfunction

The use of "renal dose" dopamine

did not reduce peak creatinine, the
need for RRT, ICU length of stay, or
mortality.

NINDS 1995
Alteplase within 3
hours for acute
ischemic stroke

In patients presenting within 3

hours of ischemic stroke, alteplase
improved 3- month neurological
function (NNT=9) but did not
impact 24-hour symptoms or
mortality.

65.

RENAL RENAL
Replacement
Therapy Study
Investigators 2009
*Higher vs. lowerintensity
CRRT*

In patients requiring CRRT, higherintensity CVVHDF (40 ml/kg/hr) did

not improve any clinical endpoints
compared to lower intensity (25
ml/kg/hr) therapy but was associated
with a higher filter replacement rate
and hypophosphatemia.

ECASS III Hacke

2008 Alteplase 3 to
4.5 hours after acute
ischemic stroke

In patients presenting 3 to 4.5

hours of ischemic stroke (beyond
the NINDS 3 hour window), alteplase
improved 3-month favorable
outcome, but increased the rate of
symptomatic ICH. There were
pertinent new exclusion criteria that
were not present in NINDS.

66.

Allen 1983
Nimodipine for
cerebral vasospasm
Among patients
with aneurysmal
SAH,

nimodipine reduced neurologic

deficit and mortality secondary to
vasospasm.

FAST Mayer 2008

rFVIIa for acute ICH

Recombinant activated factor VII

reduced hematoma growth at 24
hours, but NO clinical benefit
(death or disability at 90 days).
Arterial thromboembolic events
were more common with rFVIIa.

Dr.Sherif Badrawy

ICU Trials summary

GOLD 2007
Adjunct
*phenobarbital
for
delirium
tremens*

A protocol emphasizing escalating

diazepam doses and adjunct
phenobarbital in severe alcohol
withdrawal reduced the need for MV
compared to no treatment protocol.

77.

Esteban 2004
*Noninvasive
ventilation after
extubation failure*

In patients with the onset of

respiratory failure after extubation,
NIPPV has increased mortality, likely
dt delayed reintubation, compared
to conventional medical therapy.

78.

68.

Pickard 1989
British aneurysm
nimodipine trial

Nimodipine reduced cerebral

infarction and 3-month functional
outcomes in patients with aneurysmal
subarachnoid hemorrhage.

FACCT ARDS Net

2006 Conservative
vs. liberal fluid
management in
ARDS

Compared to liberal fluid

management in All/ ARDS,
conservative strategies did not
improve 60-day mortality, but
improved ventilator-free days and
ICU length of stay.

69.

Temkin1990
Phenytoin for
post-traumatic
seizure
prophylaxis in
severe TBI

phenytoin reduced seizures within

the first 7 days, but had no effect in
preventing late onset seizures.

79.

Meduri 1998
Meduri protocol for
unresolving ARDS
Prolonged, lowdose
methylprednisolone
in unresolving ARDS

improved ICU survival and lung

function; however, some experts
believe that larger studies are
necessary in order to characterize the
efficacy and safety of this regimen in
unresolving ARDS.

Temkin 1999
Valproate for
post-traumatic
seizure
prophylaxis in
severe TBI

valproate does not provide any

benefit over phenytoin in reducing
early or late seizures and may increase
2-year mortality.

80.

Meduri 2007
Meduri protocol for
early ARDS
Prolonged, lowdose
methylprednisolone
early ARDS

improved lung function,

duration of MV, ICU length of stay,
and ICU survival.

Treiman 1998
Comparison of
four treatments
for status
epilepticus

lorazepam superior to phenytoin but

equivalent to phenobarbital or
phenytoin/ diazepam.
81.

PROSEVA Guerin
2013 Prone
positioning in
severe ARDS

In patients with early, severe ARDS,

prone positioning for at least 16 hours
per day significantly reduced
mortality.

Devlin 2010
Quetiapine for
ICU delirium

Quetiapine cause a faster resolution

of delirium and prevent additional
episodes of delirium, no shorter length
of stay or mortality benefit.

82.

In patients with severe ARDS,

cisatracurium for 48 hours decreased
90- day mortality, although the analysis
was limited by unbalanced baseline
characteristics.

Yang 1991 *Rapid

shallow breathing
index
to predict weaning
failure*

In MV medical ICU patients, a rapid

shallow breathing index (RSBI or f/Vt)
cut-off of 100 breaths/min/L was the
most sensitive and specific
objective measure of extubation
success.

ACURASYS
Papazian 2010
Cisatracurium
for early ARDS

83.

ARDS Net 2000

Lower tidal
volumes for
ARDS

In patients with ALI/ ARDS, lower tidal

volume MV improved mortality
compared to traditional tidal volumes.

Niewoehner 1999
Steroids for COPD
exacerbations

corticosteroids Rx failure and

hospital length of stay but
hyperglycemia

84.

75.

Bouchard 2005
*Noninvasive
ventilation for
acute COPD
exacerbation*

acute COPD exacerbation who do not

require immediate intubation,
noninvasive ventilation reduced the
need for endotracheal intubation,
length of stay, and mortality.

TracMan Young
2013 Early vs. late
tracheostomy

In patients likely to require at

least 7 days of MV, early
tracheostomy did not improve
mortality but was associated with a
higher rate of unnecessary
tracheostomy compared to late
tracheostomy.

76.

CESAR Peek
2009
Conventional
vent support vs.
ECMO for ARDS

In patients with early ARDS, transfer to

a facility specializing in ARDS with the
ability to initiate ECMO was associated
with an improvement in 6-month survival
without severe disability.

85.

CRASH-2
Collaborators 2010
Tranexamic acid
in trauma patients

Tranexamic acid all-cause

mortality in a broad population of
trauma patients without an increase
in vascular occlusion
complications.

67.

70.

71.

72.

73.

74.

Dr.Sherif Badrawy

ICU Trials summary

86.

CALORIES Harvey 2014 Early

enteral vs. parenteral nutrition

Among a heterogeneous ICU patient population, there was no difference in mortality

between exclusive enteral and parenteral nutrition support.

87.

TRISS Holst 2014 Low vs. high

blood transfusion threshold in septic
shock

no difference in mortality with a lower (7 g/ dL) transfusion threshold compared to

a higher (9 g/ dL) threshold. A lower threshold was associated with less use of blood
transfusions.

88.

ARISE 2014 Early goal-directed

therapy versus usual care in early
septic shock

no difference in mortality between usual care (without SCv02) and early goaldirected therapy (based on the Rivers 2001 protocol).

Dr.Sherif Badrawy