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临床试验/NCT03907631
NCT03907631进行中(未招募)不适用

Elevate ASUC - Evaluating Clinical and Endoscopic Variables in Assessment, Treatment and Outcome Endpoints in Acute Severe Ulcerative Colitis

Hull University Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2019年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
189
试验地点
1
主要终点
In Hospital Outcomes

研究概览

简要总结

Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the emergency admission. Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic and laboratory data.

详细描述

ASUC can be a life threatening condition for which optimal management strategies within the acute setting are required. Such strategies remain largely ill-defined with approximately 30 - 40% of ASUC inpatient admissions requiring emergency colectomy.

Intravenous corticosteroids have been the mainstay of management during the inpatient admission but approximately 40% of this patient group will be steroid resistant. Although mortality following emergency colectomy has indeed fallen over time, it still remains as high as 10% at the 12 week marker. Patients with steroid refractory disease salvage therapy with infliximab can be considered to avoid colectomy.

Currently there are no predictive indices to identify patients needing rescue therapy. Hence health care professionals have no tools to 'personalise' care for ASUC by predicting up front which patients fail initial medical therapy and thus predict those who may benefit from rescue therapy or early surgery.

Traditionally the Truelove and Witts severity Index is used to define the clinical severity of disease on admission, but this long-standing index has yet to be validated as a predictor for the need for colectomy during the acute hospitalised phase. Similarly, endoscopic indices, including the only validated endoscopic severity score in UC (UCEIS - Ulcerative Colitis Endoscopic Index of Severity) have not been prospectively evaluated in the setting of ASUC.

Approximately 30% of ASUC patients treated with rescue anti TNF will fail to respond and require urgent colectomy. The optimal dosing regimes for rescue therapy with infliximab remains uncertain.Recently, there have been reports of increasing use of accelerated induction anti - TNF regimes in patients with ASUC (10mg/kg or shorter intervals) despite lack of clear evidence to support this practice. Randomised trial evidence for selecting patients suitable for accelerated induction regimes is not yet currently available and will require large sample size to elucidate clearly the variables that predict the need for individual dosing strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 - 80 years.
  • Confirmed acute severe ulcerative colitis based on modified Truelove and Witts criteria requiring hospital admission.
  • Need for at least 2 days of intravenous steroids
  • Able to sign consent

排除标准

  • Crohn's disease
  • Admission for elective colectomy
  • Infective colitis confirmed on stool culture, assays for C. difficile or cytomegalovirus
  • Pregnancy
  • Inability to sign consent
  • Prior colitis related surgery - pouch, stoma

研究组 & 干预措施

Acute Severe Ulcerative Colitis

Patients hospitalised for acute severe ulcerative colitis will be invited to participate. Participants will be treated at the discretion of their treating physicians as per standard of care. We expect some participants will undergo an endoscopic assessment, some participants will be treated with standard versus accelerated infliximab dosing, permitting comparisons, in addition to other treatment strategies.

干预措施: Standard of care (Other)

结局指标

主要结局

In Hospital Outcomes

时间窗: 30 days

Response assessed by the following clinical care decisions based on binary outcomes: need for rescue therapy (yes = 1 or no =), need for accelerated induction (yes = 1 or no = 0), need for surgery during index admission (yes = 1 or no = 0)

Colectomy rates

时间窗: 30 days

Proportion of patients needing colectomy

次要结局

  • Long-term response to medical management(day 90 and 12 month time points)
  • Risk factors for need for rescue(30)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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