Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children (NCT01757899) | Clinical Trial Compass
WithdrawnPhase 2
Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children
Stopped: Technical problems
Brazil0Started 2014-01
Plain-language summary
The purpose of this study is to investigate the effects of prolonged low-dose methylprednisolone infusion on pulmonary function (LIS and ventilation-free days), extra pulmonary organ function (PMODS score), inflammatory markers - RCP (Reactive C Protein), IL6 (Interleukine 6), TNFα (Tumor Necrosis Factor), IL8 (Interleukine 8), IL10 (Interleukine 10) and length of Pediatric Intensive Care Unit (PICU) stay in early ALI/ARDS in children.
Who can participate
Age range29 Days – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of ALI/ARDS within the first 72 hours based on all of the following criteria:
* Respiratory failure requiring mechanical ventilation - via endotracheal intubation or noninvasive positive pressure ventilation;
* Acute onset of bilateral pulmonary densities on chest radiograph in the context of appropriate predisposing injury or illness with no evidence of left ventricular failure;
* Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2:FiO2 ) ≤ 300 (criteria for ALI) or 200 (criteria for ARDS) with FiO2 ≥ 0,5 and PEEP = 5 cmH2O.
* To sign the Informed Consent to participate.
Exclusion Criteria:
* ALI/ARDS with more than 72 hours of diagnosis
* Failure to obtain written informed consent to participate in the study;
* Condition requiring \> 0.5mg/Kg/day of prednisone equivalent (i.e., acute asthma or bronchopulmonary dysplasia)
* Patients enrolled in another experimental (interventional) protocol within the past 30 days, which might adversely impact on the results of this study as determined by the investigators;
* Primary or secondary neuromuscular dysfunction
* Patients using aminoglycosides combined with neuromuscular blockers
* Cardiopulmonary arrest within 7 days or anytime during present hospitalization prior to enrollment;
* Irreversible cessation of all brain function;
* Immunosuppression, including HIV+ status, history of bone marrow or solid organ transplantation, current malignancy, neutropenia, rec…