Prospective comparison of Oxford index, AIIMS index and Admit-ASC index to predict steroid response in patients with acute severe ulcerative colitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical accuracy of Oxford index, AIIMS INDEX and ADMIT-ASC index for prediction of steroid responsiveness on day 1 and day 3 in patients with ASUC
研究概览
简要总结
Acute severe ulcerative colitis (ASUC) is a medical emergency diagnosed by Truelove and Witt’s criteria that require urgent hospitalization & aggressive management. Approximately 15-25% of patients with ulcerative colitis experience a severe flare during the course of their disease. Of these, consistent data have shown that 30–40% of patients will fail to respond to steroid therapy and require rescue therapy or urgent colectomy. The mortality associated with such attacks has fallen from levels of 31–61% to the present level of 1–2% following the introduction of high-dose corticosteroid therapy and the acceptance of a policy of early surgery in patients not responding to medical therapy. Oxford index, index and ADMIT-ASC index are needed to be compared prospectively for the best use to predict steroid responsiveness in patients with ASUC. So, this study will be aimed at prospective comparison of Oxford index, AIIMS index and ADMIT-ASC index to predict steroid response in patients with acute severe ulcerative colitis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with age ≥18 years
- •Patients presenting with a diagnosis of ASUC as defined by Truelove and Witt’s criteria.
排除标准
- •Age ≤ 18 years
- •Patients who received IV steroids before admission
- •Patients with CMV colitis
- •Patients with Crohn’s colitis.
结局指标
主要结局
Clinical accuracy of Oxford index, AIIMS INDEX and ADMIT-ASC index for prediction of steroid responsiveness on day 1 and day 3 in patients with ASUC
时间窗: January 2024 to October 2025
次要结局
- Differences in disease characteristics (duration, extent), prior treatment history & biochemical parameters(baseline hemoglobin, serum(albumin level) between steroid failure & steroid responders at day 7.)
- Difference in median CRP level & baseline fecal calprotectin level at day 1 & day 3 between steroid failure & steroid responders.(January 2024 to October 2025)
研究者
Dr Mans Kumar Panigrahi
All India Institute of Medical Sciences, Bhubaneswar