Trial Details

Recruiting
Basic Information
Clinical ID c2818
Identifier CTRI/2017/10/010160
Trial Title Evaluation of a Peri-Operative Low Dose Steroid Regimen for Steroid Treated Inflammatory Bowel Disease patients A Prospective Randomised Study
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Health Condition 1: null- patient having infalmmatory bowel disease and has taken steroids for at least 1 week in the preceding 1 year_
Interventions Intervention1: Low dose Steroid (LDS) Regimen: Patients allotted to this regimen were given hydrocortisone equivalent to their immediate pre-operative dose of prednisolone or hydrocortisone by continuous intravenous infusion starting from the time of induction, upto a maximum of 10mg/hour or 240mg/day. On POD1 the dose was reduced to 3/ followed by 1/2 on POD2, 1/3rd from POD3, to a minimum of 50mg hydrocortisone per day which was converted to oral prednisolone equivalent as soon as oral intake was started and was tapered at 5 mg per week. Patients not taking steroids at the time of surgery who are allotted to this regimen, were not given any steroids in the peri-operative period Control Intervention1: High-Dose Steroid (HDS) Regimen: Patients allotted to this regimen received 100 mg of hydrocortisone at the time of induction followed by 100 mg every 8 hours for 3 days, 100 mg twice a day for 3 days, 100 mg morning and 50 mg in evening for 3 days. As soon as the patients are able to take orally, they were given prednisolone in a dose equivalent to the last dose of hydrocortisone received. Further tapering was done in a dose equivalent to prednisolone 10 mg every week, until a dose of 10mg OD which was then tapered by 5mg weekly
Participant Information
Sponsor AIIMS
City -
Country/Region India
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE2|PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -