Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
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.


Options:
A: Arm Label: methylprednisolone; Type: EXPERIMENTAL; Interventions: Drug: intravenous methylprednisolone | Arm Label: normal saline solution; Type: PLACEBO_COMPARATOR; Interventions: Other: intravenous normal saline solution | Intervention Type: DRUG; Name: intravenous methylprednisolone; Assigned to Arm(s): methylprednisolone | Intervention Type: OTHER; Name: intravenous normal saline solution; Assigned to Arm(s): normal saline solution
B: Arm Label: EN only; Type: EXPERIMENTAL; Interventions: Other: Withholding PN during the first week of ICU stay | Arm Label: EN plus early PN; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E | Intervention Type: OTHER; Name: Withholding PN during the first week of ICU stay; Assigned to Arm(s): EN only | Intervention Type: DRUG; Name: Oliclinomel N71000 OR N71000E // Clinimix N17G35 OR N17G35E; Assigned to Arm(s): EN plus early PN
C: Intervention Type: DRUG; Name: Mythylprednisolone; Assigned to Arm(s): N/A
D: Arm Label: NMES; Type: EXPERIMENTAL; Interventions: Device: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA) | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Sham | Intervention Type: DEVICE; Name: Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA); Assigned to Arm(s): NMES | Intervention Type: DEVICE; Name: Sham; Assigned to Arm(s): Sham

Answer: A