Overview

This trial is active, not recruiting.

Conditions acute respiratory distress syndrome (ards), acute lung injury (ali)
Treatments methylprednisolone, normal saline (0.9%)
Phase phase 2
Sponsor University of Tennessee
Start date October 2010
End date January 2014
Trial size 100 participants
Trial identifier NCT01274260, Steroids in Pediatic ALI/ARDS

Summary

Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children.

Hypothesis:

Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Intervention: Subjects in this study group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.
methylprednisolone
Subjects in this group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.
(Placebo Comparator)
Intervention: The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline. The placebo group with receive the masked study drug in infusion rates that mimic the infusions received by the experimental group.
normal saline (0.9%)
The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.

Primary Outcomes

Measure
Duration of mechanical ventilation
time frame: 0-28 days

Secondary Outcomes

Measure
Improvement in oxygenation
time frame: 0-28 days
Incidence of nosocomial infections
time frame: 0-35 days
Incidence of hyperglycemia
time frame: 0-28 days

Eligibility Criteria

Male or female participants from 1 month up to 18 years old.

Inclusion Criteria: 1. Between 1 month and 18 years of age; AND 2. Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by: 1. acute onset of the disease, 2. PaO2/FiO2 ratio <300, 3. evidence of bilateral infiltrates on chest radiography, and 4. no evidence of cardiac dysfunction; AND 3. Intubated and mechanically ventilated. Exclusion Criteria: 1. Underlying disease requiring steroids >0.5mg/kg/day of methylprednisolone (eg. Asthma) 2. HIV positive, or have any other congenital or acquired immunodeficiency; 3. Terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care 4. Cytotoxic therapy within the past 3 weeks 5. Major gastrointestinal bleeding within last 1 month 6. Extensive burns (>20% total body surface area of full- or partial-thickness burns) 7. Known or suspected adrenal insufficiency 8. Vasculitis or diffuse alveolar hemorrhage 9. Bone marrow or lung transplant 10. Disseminated fungal infections 11. Severe chronic liver disease 12. Other conditions with estimated 6-month mortality of 50% or higher

Additional Information

Official title Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Tennessee.