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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01281748
Recruitment Status : Terminated (Low rate of enrollment)
First Posted : January 24, 2011
Last Update Posted : January 24, 2011
Information provided by:
Hospital Universitario Getafe

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.

Condition or disease Intervention/treatment Phase
COPD Drug: intravenous methylprednisolone Other: intravenous normal saline solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 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).

  2. Need for intubation in patients treated with non-invasive mechanical ventilation [ Time Frame: Participants are followed until ICU discharge ]
    Number of patients intubated in the following 48 hours after the initiation of non-invasive mechanical ventilation

  3. Length of ICU stay [ Time Frame: Participants are followed until ICU discharge ]
    Time elapsed between ICU admission and ICU discharge (dead or alive)

Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: Participants are followed until ICU discharge ]
    Number of participants who die in the ICU

  2. Length of hospital stay [ Time Frame: Participants are followed until hospital discharge ]
    Time elapsed between hospital admission and hospital discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01281748

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Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Sponsors and Collaborators
Hospital Universitario Getafe
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Inmaculada Alía, Miguel Angel de la Cal and Andrés Esteban, Hospital Universitario de Getafe Identifier: NCT01281748    
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: May 2005
Keywords provided by Hospital Universitario Getafe:
acute exacerbation of COPD
Additional relevant MeSH terms:
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Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents