1. 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.
3. 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
6. 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.
7. 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.
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 90-
day 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.
ICU Trials Summary
Study online at quizlet.com/_1myscj
ICU Trials summary
Dr.Sherif Badrawy
Dr.
Sherif
Badrawy
Digitally signed by Dr.
Sherif Badrawy
DN: cn=Dr. Sherif
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ou=Critical Care,
email=sherif_badrawy
@yahoo.com, c=SA
Date: 2015.10.22
04:48:18 +03'00'
2. 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 goal-
directed therapy
for
severe sepsis and
septic shock
❀ improved resuscitation parameters
and reduced mortality.
20. ProCESS ➜ The
ProCESS
Investigators
2014 ➜ EGDT, and
a no-protocol
usual-therapy
approach
❀ all equally effective in treating early
septic shock patients.
21. 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 .Hypothesis-
generating subgroup analysis indicated
that trauma patients may benefit from
normal saline whereas septic shock
patients may benefit from albumin.
22. 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.
25. 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.
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. standard-
dose 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.
ICU Trials summary
Dr.Sherif Badrawy
3. 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.
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.
36. BERNARD 2002 ➜
*Australian
hypothermia
study
for out-of-
hospital arrest*
❀ Therapeutic hypothermia improved
the incidence of favorable discharge
disposition and a trend towards
improved mortality.
37. HACA ➜ HACA
Study Group 2002
European
hypothermia
study for out-of-
hospital arrest
❀ Therapeutic hypothermia improved
6- month neurologic outcome and
mortality
38. TTM ➜ Nielsen
2013 ➜
Therapeutic
hypothermia
with 33°C versus
36°C In patients
with out-of-
hospital cardiac
arrest with ROSC
❀ , there was no difference in longterm
mortality between therapeutic
hypothermia with 36°C and 33°C.
39. BOZZETTE 1990 ➜
Adjunctive
corticosteroids in
patients with
AIDS and
pneumocystis
pneumonia
❀ improved mortality and respiratory
failure among patients with moderate-
to-severe pneumonia, although steroid
therapy increased the risk of herpes
reactivation and oral thrush.
40. CHASTER 2003 ➜ 8
vs. 15 days of
antibiotics for
VAP in late-onset
VAP or early-
onset VAP with
recent antibiotic
exposure
❀ 8-days was non-inferior to 15- days
of appropriate antibiotic therapy for
mortality and pneumonia recurrence.
41. 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]
42. PROTRATA ➜
Bouadma 2010 ➜
Procalcitonin
algorithm for
guiding antibiotic
therapy
❀ reduced antibiotic exposure but
did not directly improve patient
outcomes.
43. SORT 1999 ➜
Albumin for
spontaneous
bacterial
peritonitis
❀ reduced renal impairment and
mortality compared to placebo.
44. 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
❀ 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
❀ 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. 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. MENDS ➜
Pandharipande
2007 ➜
Dexmedetomidine
vs lorazepam in
mechanically
ventilated
patients
❀ dexmedetomidine improved coma-
free days and time within goal level of
sedation compared to lorazepam, but
required more open-label fentanyl
and had a higher incidence of
bradycardia.
ICU Trials summary
Dr.Sherif Badrawy
4. 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.
52. OSCAR ➜ Young
2013 ➜ High-
Frequency
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.
53. 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.
54. 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.
55. STROM 2010 ➜
Sedationless MV
A protocol for little
or no sedation
among MV patients
❀ reduced the duration of MV and
ICU length of stay, although it may
increase the incidence of delirium.
56. 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.
57. RENAL ➜ RENAL
Replacement
Therapy Study
Investigators 2009
➜*Higher vs. lower-
intensity
CRRT*
❀ In patients requiring CRRT, higher-
intensity 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.
58. Allen 1983 ➜
Nimodipine for
cerebral vasospasm
Among patients
with aneurysmal
SAH,
❀ nimodipine reduced neurologic
deficit and mortality secondary to
vasospasm.
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. 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. 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. 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. 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.
ICU Trials summary
Dr.Sherif Badrawy
5. 67. 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.
68. Pickard 1989 ➜
British aneurysm
nimodipine trial
❀ Nimodipine reduced cerebral
infarction and 3-month functional
outcomes in patients with aneurysmal
subarachnoid hemorrhage.
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.
70. 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.
71. Treiman 1998 ➜
Comparison of
four treatments
for status
epilepticus
❀ lorazepam superior to phenytoin but
equivalent to phenobarbital or
phenytoin/ diazepam.
72. 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.
73. ACURASYS ➜
Papazian 2010 ➜
Cisatracurium
for early ARDS
❀ In patients with severe ARDS,
cisatracurium for 48 hours decreased
90- day mortality, although the analysis
was limited by unbalanced baseline
characteristics.
74. ARDS Net 2000 ➜
Lower tidal
volumes for
ARDS
❀ In patients with ALI/ ARDS, lower tidal
volume MV improved mortality
compared to traditional tidal volumes.
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.
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.
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. 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.
79. Meduri 1998 ➜
Meduri protocol for
unresolving ARDS
Prolonged, low-
dose
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.
80. Meduri 2007 ➜
Meduri protocol for
early ARDS
Prolonged, low-
dose
methylprednisolone
early ARDS
❀ improved lung function,
duration of MV, ICU length of stay,
and ICU survival.
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.
82. 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.
83. Niewoehner 1999 ➜
Steroids for COPD
exacerbations
❀ corticosteroids ⇩Rx failure and
hospital length of stay but
⇧hyperglycemia
84. 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.
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.
ICU Trials summary
Dr.Sherif Badrawy
6. 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 goal-
directed therapy (based on the Rivers 2001 protocol).
ICU Trials summary
Dr.Sherif Badrawy