jRCTs031230684招募中不适用
Low-Methoxy Pectin containing Enteral nutrition in Critically care for intestinal Tolerance (LOME-PECT trial)
未提供0 个研究点目标入组 200 人开始时间: 2024年8月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •(1)Patients admitted to ICU (regardless of reason for admission)
- •(2)Patients aged 18 years of age or older at the time of enrolment
- •(3)Patients indicated for EN by transgastric administration
- •(4)Patients who have given written, free and voluntary consent to participate in this study, either by themselves or by a surrogate
排除标准
- •(1)Patients for whom EN had been performed within 30 days prior to enrollment
- •(2)Patients with diarrhea at enrollment; Bristol scale >=5 (Bristol scale 5, 6, or 7 points)
- •(3)Patients with contraindications or medical inappropriateness (including allergies) to EN by transgastric administration of this nutrient
- •(4)Patients with DNR/BSC policy
- •(5)Patients for whom EN is performed by PEG/PTEG
- •(6)Other cases judged as inappropriate by the investigator
结局指标
主要结局
-
Incidence of diarrhea within 3 days of study product administration
次要结局
- Bristol Scale diarrhea(days 1, 2, and 3 of treatment)
- Diarrhea (Bristol Scale 5, 6, or 7)(first week after the start of treatment)
- Failure rate of EN(days 3 and 7 of treatment)
- Duration of EN administration
- Daily energy and protein dose(first 7 days after the start of treatment)
- Survival rate(28 days after the start of the study product administration)
- Number of days in ICU
- Hospitalization days
- Number of ventilatory days
- Nutritional endpoints(days 7 and 14)
- Barthel Index(day 28 after the start of treatment)
- Incidence of intestinal intolerance events
- Incidence of infectious events(28 days of study product administration)
研究者
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