Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD |
Drug: intravenous methylprednisolone Other: intravenous normal saline solution |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
- Duration of mechanical ventilation [ Time Frame: Participants are followed until ICU discharge ] [ Designated as safety issue: No ]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 [ Time Frame: Participants are followed until ICU discharge ] [ Designated as safety issue: No ]Number of patients intubated in the following 48 hours after the initiation of non-invasive mechanical ventilation
- Length of ICU stay [ Time Frame: Participants are followed until ICU discharge ] [ Designated as safety issue: No ]Time elapsed between ICU admission and ICU discharge (dead or alive)
- ICU mortality [ Time Frame: Participants are followed until ICU discharge ] [ Designated as safety issue: Yes ]Number of participants who die in the ICU
- Length of hospital stay [ Time Frame: Participants are followed until hospital discharge ] [ Designated as safety issue: No ]Time elapsed between hospital admission and hospital discharge
| Enrollment: | 83 |
| Study Start Date: | July 2005 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: methylprednisolone |
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
|
| Placebo Comparator: normal saline solution |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adult patients (age > 18 years) admitted to participating ICUs with:
- 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
- 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:
- Primary diagnosis of asthma exacerbation.
- History of asthma or atopy.
- Use of systemic corticosteroids within the preceding month.
- Use of systemic corticosteroids for the treatment of COPD exacerbation at the time of ICU admission for more than 24 hours.
- Clinical or radiological evidence of pneumonia.
- Uncontrolled left-ventricular failure (patients with evidence of severe heart failure requiring inotropes or vasoactive drugs).
- Uncontrolled hypertension arterial (systolic pressure > 180 mm Hg or diastolic pressure > 90 mm Hg despite antihypertensive therapy).
- Uncontrolled diabetes mellitus.
- Presence of a neuromuscular disease.
- History of allergy and or adverse reaction to corticosteroids.
Contacts and Locations More Information
No publications provided by Hospital Universitario Getafe
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Inmaculada Alía, Miguel Angel de la Cal and Andrés Esteban, Hospital Universitario de Getafe |
| ClinicalTrials.gov Identifier: | NCT01281748 History of Changes |
| Other Study ID Numbers: | CORTICOSTEROIDS AND ACUTE COPD |
| Study First Received: | January 20, 2011 |
| Last Updated: | January 21, 2011 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Keywords provided by Hospital Universitario Getafe:
|
acute exacerbation of COPD |
Additional relevant MeSH terms:
|
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013