A clinical trial to evaluate the effect of low dose steroid in decreasing lung injury occurring in burn patients

Not Applicable

Conditions: Health Condition 1: X088- Exposure to other specified smoke,fire and flames

Registration Number: CTRI/2022/10/046396

Lead Sponsor: AIIMS New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients aged 18-65 years with severe burns (more than 20% total body surface area excluding areas of superficial burn) with early (within 72 hrs of onset) mild to moderate ARDS according to definition by BerlinÃ¢â?¬•s criteria (p/f ratios 150 to Ã¢â?°Â¤ 300) within 10 days history of burns

Exclusion Criteria

a) Age <18 years and >65 years

b) Patients with p/f ratios <150

c) Burns < 205 total body surface area

d) Moribund state (i.e., not expected to survive more than 24 hr)

e) Advanced malignancy with life expectancy <6 months

f) Pregnancy

g) Patients on immunosuppressive therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time adjusted PaO2/ FiO2 ratios over the first 7 days from randomisationTimepoint: Survival time adjusted PaO2/ FiO2 ratios over the first 7 days from randomisation

Secondary Outcome Measures

Name	Time	Method
To evaluate the following: <br/ ><br>a) Ventilator free days <br/ ><br>b) ICU length of stay & ICU mortality <br/ ><br>c) Incidence of adverse events like hyperglycemia, nosocomial infections & gastrointestinal bleeding <br/ ><br>d) Number of patients initially on non-invasive ventilation requiring invasive ventilation <br/ ><br>e) Lung injury scores (comprising of PaO2/FiO2 ratios, PEEP, lung compliance & x ray chest findings) <br/ ><br>f) Daily SOFA scores <br/ ><br>Timepoint: a) Measured by subtracting the number of days free from ventilator at day 28 from start of mechanical ventilation <br/ ><br>b) Total duration of ICU stay and percentage of deaths occurring during ICU stay <br/ ><br>c) Measured daily till ICU discharge/ mortality <br/ ><br>d) Measured daily till ICU discharge/ mortality <br/ ><br>e) Measured daily till ICU discharge/ mortality <br/ ><br>f) Measured daily till ICU discharge/ mortality