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

Low dose methylprednisolone in early mild-moderate ARDS in burn patients: A single centre open label randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046396
Enrollment
70
Registered
2022-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Low dose methylprednisolone: Methylprednisolone 1mg/kg bodyweight will be administered for a duration of atleast 7 days after randomisation, the decision to continue the drug will be at

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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 Berlinââ?¬•s criteria (p/f ratios 150 to ââ?°Â¤ 300) within 10 days history of burns

Exclusion criteria

Exclusion criteria: a) Age 65 years b) Patients with p/f ratios c) Burns d) Moribund state (i.e., not expected to survive more than 24 hr) e) Advanced malignancy with life expectancy f) Pregnancy g) Patients on immunosuppressive therapy

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactMadhurjya Baishya

AIIMS, New Delhi

drshail.kumar@gmail.com8745027472

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026