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A study to know if Methylprednisolone(a steroid drug used to decrease inflammation) helps in reducing the narrowing of food pipe (a common complication after corrosive ingestion)

Role of Methylprednisolone in Corrosive Esophageal Injury : A Randomised controlled open label study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027532
Enrollment
30
Registered
2020-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Intervention1: Methylprednisolone pulse therapy: Injection Methylprednisolone 1gm in 100 ml NS intravenously over 30 min once a day x 3 days Control Intervention1: Normal Saline 100 ml(placebo): Injec

Sponsors

AIIMSNew Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consecutive patients with history of acute corrosive ingestion with Zargar endoscopy grade IIb esophageal injury. 2. Age > 18 years 3.Valid consent given by the patient for the study.

Exclusion criteria

Exclusion criteria: 1. Esophageal injury other than endoscopic Zargar grade IIb (Zargar grade I, IIa& III will be excluded). 2. Hemodynamic unstable patient 3. Patients who has received Cardiopulmonary Resuscitation (CPR) 4.Patients who needs Endotracheal intubation and mechanical ventilation 5.Patients who are not conscious 6. History of corrosive ingestion of >24 hours 7.Age 8.Patients who refused to give valid consent for the said study

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of Methylprednisolone in the prevention of corrosive injury induced esophageal strictureTimepoint: 8 weeks

Secondary

MeasureTime frame
1.To compare the possible complications like infection, sepsis, stridor, hoarseness, upper gastrointestinal bleed, Acute respiratory distress syndrome, Acute kidney injury, perforation, peritonitis and mediastinitis in both study and control group. 2.We will compare change in blood sugar level, change in blood pressure and electrolyte abnormalities in both intervention and control group. 3.To compare mortality at 8 weeks in both study and control group. Timepoint: During hospital stay till 8 weeks

Countries

India

Contacts

Public ContactDr Irtiqa Sheikh

All India Institute of Medical Sciences,New Delhi

jamshednayer@gmail.com

Outcome results

None listed

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