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

NCT01281748 | Terminated Phase 4

• 1 other identifier: CORTICOSTEROIDS AND ACUTE COPD
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

acute exacerbation of COPD

Outcome Measures

Primary Outcomes (3)

• Duration of mechanical ventilation

  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).

  Participants are followed until ICU discharge

• Need for intubation in patients treated with non-invasive mechanical ventilation

  Number of patients intubated in the following 48 hours after the initiation of non-invasive mechanical ventilation

  Participants are followed until ICU discharge

• Length of ICU stay

  Time elapsed between ICU admission and ICU discharge (dead or alive)

  Participants are followed until ICU discharge

Secondary Outcomes (2)

• ICU mortality

  Participants are followed until ICU discharge

• Length of hospital stay

  Participants are followed until hospital discharge

Study Arms (2)

methylprednisolone

EXPERIMENTAL

Drug: intravenous methylprednisolone

normal saline solution

PLACEBO COMPARATOR

Other: intravenous normal saline solution

Interventions

intravenous methylprednisolone DRUG

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

methylprednisolone

intravenous normal saline solution OTHER

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.

normal saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Getafe: lead
• GRANT IP041233 FROM FONDO DE INVESTIGACION SANITARIA: collaborator

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Related Publications (1)

• 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.

  PMID: 22123804 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 24, 2011
• Study Start: July 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 24, 2011

Record last verified: 2005-05

Locations

ES (1)