Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support
Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support
Clinical practice guidelines for the management of chronic obstructive pulmonary disease
 (COPD) recommend treatment with systemic corticosteroids during acute exacerbations. The
 results of a Cochrane systematic review show that treatment with systemic corticosteroids
 improves lung function over the first 72 hours of an exacerbation of COPD but the effect on
 other outcomes, particularly length of hospital stay, is unclear, so further research should
 be directed at determining the risk-benefit ratio, particularly those at high risk of
 developing adverse drug reactions. In critically ill patients, corticosteroid treatment is a
 risk factor of infections, hyperglucemia and critical-illness neuromuscular abnormalities,
 and these conditions are associated with an increased morbidity and mortality. The effect of
 treatment with systemic corticosteroids in COPD patients with acute exacerbation requiring
 mechanical ventilation has not been evaluated investigated so it is unknown if the
 corticosteroids could reduce the duration of mechanical ventilation and the length of
 intensive care unit (ICU) stay or if, on the contrary, the development of adverse events
 could lead to a longer time on mechanical ventilation and ICU stay.

 PRIMARY OBJECTIVES: To evaluate the effect of corticosteroids on the duration of mechanical
 ventilation, the length of ICU stay, the need for tracheal intubation in patients treated
 with non-invasive mechanical ventilation. To evaluate the frequency of adverse events:
 secondary infections, pneumonia, arterial hypertension, hyperglucemia, gastrointestinal
 bleeding, and critical-illness neuromuscular abnormalities. DESING: Multicenter, prospective,
 randomized, double blind, placebo-controlled clinical trial.The treatment group will receive
 intravenous methylprednisolone for 10 days and the control group will receive isotonic saline
 solution.
Inclusion Criteria:

 -  Adult patients (age > 18 years) admitted to participating ICUs with:

 1. Primary diagnosis of COPD exacerbation defined as the presence of two or more of
 the following clinical features: worsening dyspnea, increase in sputum purulence,
 increase in sputum volume

 2. respiratory failure [pH < 7,35 with a PaCO2 > 45 mm Hg and respiratory rate more
 than 23 breaths per minute] requiring mechanical ventilation, invasive or
 non-invasive mechanical ventilation.

 Exclusion Criteria:

 1. Primary diagnosis of asthma exacerbation.

 2. History of asthma or atopy.

 3. Use of systemic corticosteroids within the preceding month.

 4. Use of systemic corticosteroids for the treatment of COPD exacerbation at the time of
 ICU admission for more than 24 hours.

 5. Clinical or radiological evidence of pneumonia.

 6. Uncontrolled left-ventricular failure (patients with evidence of severe heart failure
 requiring inotropes or vasoactive drugs).

 7. Uncontrolled hypertension arterial (systolic pressure > 180 mm Hg or diastolic
 pressure > 90 mm Hg despite antihypertensive therapy).

 8. Uncontrolled diabetes mellitus.

 9. Presence of a neuromuscular disease.

 10. History of allergy and or adverse reaction to corticosteroids.