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临床试验/NCT02170714
NCT02170714已完成不适用

Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
The number of patients with ASC treated with IFX requiring colectomy

研究概览

简要总结

Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a second line therapy. This study was performed in consecutively observed pediatric patients with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)- European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN) guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical predictors of poor outcome.

Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All patients were treated according to the above mentioned guidelines for ASC and received intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy rate and the efficacy of IFX in avoiding colectomy were evaluated.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ASC
  • Confirmed diagnosis of ulcerative colitis (UC)
  • Age 1-18 years

排除标准

  • Not confirmed diagnosis of UC
  • Contraindications for infliximab therapy

结局指标

主要结局

The number of patients with ASC treated with IFX requiring colectomy

时间窗: 24 months

The surgical need will be evaluated in the group of patients treated with IFX during a 24-month follow-up

次要结局

  • The number of patients with ASC requiring colectomy(1,6,12,18,24 months)
  • To identify clinical predictive factors at the diagnosis of ASC of surgical need at follow-up(First day of the hospitalization)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina Aloi

Assistant Professor

University of Roma La Sapienza

研究点 (1)

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