Pulmonary Disease Treatment concerning COPD Agenda Introduce the journal article Review of preliminary background Discuss the details of the study Evaluation of the study Discuss how the implications of the study translate into practice ID: 469179
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Slide1
By Melissa Jakubowski
Pulmonary Disease Treatment concerning COPD Slide2
Agenda
Introduce the journal article
Review of preliminary background
Discuss the details of the study
Evaluation of the study
Discuss how the implications of the study translate into practice
QuestionsSlide3
Journal Article
Efficacy of corticosteroid therapy in patients with an acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory
supportSlide4
This study assessed:
T
he effect of
systemic corticosteroids on ICU patients who were mechanically ventilated (invasive or noninvasive) due to COPD exacerbationsSlide5
Importance
Previous randomized trials assessing the effect of systemic corticosteroid therapy on COPD exacerbations have excluded patients with respiratory failure who required mechanical ventilation or ICU admission
Critically ill patients in the ICU are more prone to develop complications potentially associated with corticosteroid therapySlide6
Hospital treatment for COPD
BronchodilatorsAntibioticsOxygenC
orticosteroids Slide7
COPD and Corticosteroid Therapy
COPD: airways damaged interfering with the exchange of oxygen and carbon dioxide in the lungs
F
unction
: reduce lung and bronchial tube inflammation related to tissue damage and improve respiratory functionSlide8
Short-term side effects
Increased appetiteFluid retentionWeight gain
Increased blood pressure
Hyperglycemia Slide9
Systemic steroids, corticosteroids
PrednisonePrednisoloneMethylprednisolone
Betamethasone
Beclamethasone
Dexamethasone
Flurocortisone
Hydrocortisone
TriamcinoloneSlide10
Screening for subjects
Screening: 354 patients from 8 hospitals in 4 countries from July 2005 – July 2009Criteria: hospitalization because of exacerbation of COPD requiring ventilatory support in the ICU
Controls: diagnosis of “exacerbation of COPD” was explicitly defined; patients with conditions that would alter integrity of study were excludedSlide11
Ethics
Approved by the ethics committee at each hospitalWritten informed consent obtained from patients or their surrogatesSlide12
Study population Slide13
Baseline Characteristics
Characteristic
Placebo
Group (n=40)
Corticosteroid
Group (n=43)
P
Value
Age (year)
67.6
69.1
0.52
Men (%)
34
32
0.23
SAPS II
36.3
36.3
0.99
Comorbid condition
(%)
DM
22
35
0.07
Reason
for acute exacerbation of COPD (%)
0.72
Initial
ventilatory support (%)
0.60Blood gases0.72Blood glucose (mg/dL)158.7193.30.02Slide14
Study design
Within 24 hours after ICU admission, patients randomly assigned to either corticosteroid group or placebo groupSlide15
Length of Administration: 10 days
Treatment Group
Methylprednisolone
Placebo Group
Normal saline solutionSlide16
Administration RegimenSlide17
Outcome Measures
Duration of mechanical ventilation, dLength of ICU stay, d
Length of hospital stay, d
In-ICU mortality, %
Failure of NIMV, %
Reintubation within 48 hours of planned extubation and received CMV either initially or after failure of NIMV, %Slide18
Frequency of Adverse Events
Superinfection
Gastrointestinal bleeding
Arterial hypertension
Hyperglycemia
Ventilator-associated pneumonia
Delirium
ICU-acquired paresisSlide19
Other daily measurements
ABG analysisC-reactive proteinMaximal blood glucose level
Daily dose of insulin
PEEP (positive end-expiratory pressure): only in patients who were intubatedSlide20
Results: Outcome Measures
Outcome
Placebo
Group
Corticosteroid
Group
P Value
Duration of mechanical
ventilation, d
4
3
0.04
Length
of ICU stay, d
7
6
0.09
Length of hospital
stay, d
15
13
0.30
In-ICU mortality,
%
10
12
0.81
Failure of
NIMV, %
37
0
0.004Reintubation within 48h, %19140.71Slide21
Reduction in duration of mechanical ventilationSlide22
Reduction in the Incidence of NIV FailureSlide23
Frequency of Adverse Events
Event
Placebo Group
Corticosteroid Group
P Value
Superinfection
6
5
0.65
GI bleeding
2
2
0.60
Arterial
HTN
4
2
0.42
Hyperglycemia
10
20
0.04
Vent-associated
pneumonia
3
4
0.77
Delirium
3
1
0.35
ICU-acquired paresis00…Slide24
Pros vs. Cons
Pros
Modest reduction in the duration of mechanical ventilation
Increased success of NIMV
Trend towards shorter ICU stay
Cons
HyperglycemiaSlide25
Evaluation of the study:
Pros
1
st
study to confirm the benefits of systemic corticosteroid therapy for ICU patients receiving MV for COPD exacerbation
Validates its usage in clinical practice today
Double-blinded experiment
Source of fundingSlide26
Pros (continued)
Funded by University of Vall d’Hebron
Hospital, Laboratory of Experimental Cardiology (LEC)
LEC mission statement: “to
contribute to lessen the impact of cardiovascular diseases on survival capacity and quality of life of the general population by elucidating the mechanisms of disease and proposing new
treatments”Slide27
Evaluation of the study: Cons
Results will not have an impact on current clinical treatment practice guidelines
Sample size was small (83)
Length of study (5 years)
Does not mention the effect of the drug on eating behavior Slide28
Resource
Alia I, de la Cal MA, Esteban A, et al. Efficacy of corticosteroid therapy in patients with an acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support.
Arch Intern Med.
2011;171(21):1939-1946. Accessed April 13, 2012.Slide29
Additional thoughts
What about corticosteroid long-term side-effects?
Optimal dose and
length of treatment?
How do the findings
translate into
practice?Slide30
Questions