Clinical trial NCT01281748: Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: COPD
Keywords: acute exacerbation of COPD
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
Collaborators: name: GRANT IP041233 FROM FONDO DE INVESTIGACION SANITARIA
First posted: 2011-01-24
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Participants are followed until ICU discharge
measure: Need for intubation in patients treated with non-invasive mechanical ventilation
timeFrame: Participants are followed until ICU discharge
measure: Length of ICU stay
timeFrame: Participants are followed until ICU discharge
Secondary outcomes:
measure: ICU mortality
timeFrame: Participants are followed until ICU discharge
measure: Length of hospital stay
timeFrame: Participants are followed until hospital discharge
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
References:
citation: Alia I, de la Cal MA, Esteban A, Abella A, Ferrer R, Molina FJ, Torres A, Gordo F, Elizalde JJ, de Pablo R, Huete A, Anzueto A. Efficacy of corticosteroid therapy in patients with an acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support. Arch Intern Med. 2011 Nov 28;171(21):1939-46. doi: 10.1001/archinternmed.2011.530.