Trial of Steroids in Pediatric Acute Lung Injury/ARDS

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— SPALIT  

Official title:

Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01274260
• Other study ID #: Steroids in Pediatic ALI/ARDS
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 9, 2011
• Last updated: May 23, 2014
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Lung Injury (ALI)
• Acute Respiratory Distress Syndrome (ARDS)
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• 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.
• Normal Saline (0.9%)
The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.

Locations

Country	Name	City	State
United States	Le Bonheur Children's Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	Number of hours required for positive pressure ventilation after the start of study drug	0-28 days	No
Secondary	Improvement in oxygenation	Differences in the PaO2/FiO2 ratios between the two randomized groups	0-28 days	No
Secondary	Incidence of nosocomial infections	Infection surveillance will be in the form of tracheal aspirate for gram stain and culture done prior to study entry and then every 3-5 days. If a subject spikes a fever during the study drug infusion, they will have blood, urine and tracheal aspirate cultures done along with CBC and CRP. Number of nosocomial infections documented via surveillance cultures will be compared between groups.	0-35 days	Yes
Secondary	Incidence of hyperglycemia	Number of times that the subject has a Blood Glucose >180 mg/dL (10 mmol/L) will be compared between the randomized groups	0-28 days	Yes