Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Instituto D'Or de Pesquisa; Instituto de Puericultura e Pediatria Martagão Gesteira - IPPMG/UFRJ; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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, receiving cytotoxic therapy for any reason, and acute burn injury;

• Severe chronic liver disease (Child-Pugh Class C score > 10 points).