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

This study has been terminated.
(Low rate of enrollment)
Sponsor:
Collaborator:
GRANT IP041233 FROM FONDO DE INVESTIGACION SANITARIA
Information provided by:
Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01281748
First received: January 20, 2011
Last updated: January 21, 2011
Last verified: May 2005

January 20, 2011
January 21, 2011
July 2005
July 2009   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01281748 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluation Of The Efficacy Of Corticosteroids In Patients With An Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Receiving Ventilator Support
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
COPD
  • 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.
  • Experimental: methylprednisolone
    Intervention: Drug: intravenous methylprednisolone
  • Placebo Comparator: normal saline solution
    Intervention: Other: intravenous normal saline solution
Alía 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
83
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01281748
CORTICOSTEROIDS AND ACUTE COPD
Not Provided
Inmaculada Alía, Miguel Angel de la Cal and Andrés Esteban, Hospital Universitario de Getafe
Hospital Universitario Getafe
GRANT IP041233 FROM FONDO DE INVESTIGACION SANITARIA
Not Provided
Hospital Universitario Getafe
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP