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Peri-operative steroids for IBD patients - will a lower dose suffice?

Evaluation of a Peri-Operative Low Dose Steroid Regimen for Steroid Treated Inflammatory Bowel Disease patients â?? A Prospective Randomised Study

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010160
Enrollment
118
Registered
2017-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

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 continu

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with IBD receiving steroids at the time of surgery or who have received steroids for a continuous period of one week during the preceding 1 year

Exclusion criteria

Exclusion criteria: 1.Patients not consenting to the study (were given high dose steroids as per existing practice) 2.Pre-operative hypotension as defined by systolic blood pressure 3.History of haemodynamic complications after withdrawal of steroids 4.Patients who were treated with oral budesonide

Design outcomes

Primary

MeasureTime frame
absence of postural hypotension on POD 1Timepoint: absence of postural hypotension on POD 1

Secondary

MeasureTime frame
Absence of any haemodynamic instabilityTimepoint: till discharge;Absence of any postural hypotension till POD-7, or discharge, whichever is earlierTimepoint: POD 2 to POD 7;Any complications in the 30-day postoperative periodTimepoint: till POD 30;Any episode of heart rate 100 or 60 beats per minuteTimepoint: till POD7;any rescue steroids required to correct hypotensionTimepoint: till discharge

Countries

India

Contacts

Public ContactSrinivasan Ramachandran

All India Institute of Medical Sciences

sujoypal@hotmail.com9868045609

Outcome results

None listed

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