COPD
Conditions
Keywords
acute exacerbation of COPD
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.
Interventions
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
OTHERintravenous 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.
Sponsors
GRANT IP041233 FROM FONDO DE INVESTIGACION SANITARIA
Hospital Universitario Getafe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | Participants are followed until ICU discharge | Time elapsed between tracheal intubation and extubation (in the group of patients treated with invasive mechanical ventilation),or time elapsed between initiation of non-invasive mechanical ventilation and withdrawal of non-invasive mechanical ventilation (in the group of patients successfully treated with non-invasive mechanical ventilation, or time elapsed between initiation of non-invasive ventilation and extubation (in the case of those patients who failed non-invasiev ventilation and required tracheal intubation). |
| Need for intubation in patients treated with non-invasive mechanical ventilation | Participants are followed until ICU discharge | Number of patients intubated in the following 48 hours after the initiation of non-invasive mechanical ventilation |
| Length of ICU stay | Participants are followed until ICU discharge | Time elapsed between ICU admission and ICU discharge (dead or alive) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | Participants are followed until ICU discharge | Number of participants who die in the ICU |
| Length of hospital stay | Participants are followed until hospital discharge | Time elapsed between hospital admission and hospital discharge |
Countries
Spain
Outcome results
None listed