Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support

Hospital Universitario Getafe

Status and phase: Terminated; Phase 4

Conditions: COPD

Treatments: Drug: intravenous methylprednisolone; Other: intravenous normal saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01281748

CORTICOSTEROIDS AND ACUTE COPD

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

methylprednisolone

Experimental group

Treatment:

Drug: intravenous methylprednisolone

normal saline solution

Placebo Comparator group

Treatment:

Other: intravenous normal saline solution