NCT01281748

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Hospital Universitario Getafe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	intravenous methylprednisolone	methylprednisolone 0,5 mg/kg every 6 hours for 72 hours, 0,5 mg/kg every 12 hours on days 4 through 6, 0,5 mg/kg daily for day 7 through day 10
OTHER	intravenous normal saline solution	50 ml of intravenous normal saline solution every 6 hours for 72 hours, 50 ml every 12 hours on days through 6, 50 ml daily for day 7 through day 10.

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2011-01-24
• Last updated: 2011-01-24

Locations

1 site across 1 country: Spain