Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
赞助:
Ain Shams University
合作者:
信息的提供 (责任方):
Eman Mohamed El Mokadem，Future University in Egypt
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 4, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Gastric Residual Volume[ Time Frame: 7 days ] Gastric residual volume as a surrogate to gastric emptying by means of gastric ultrasound. of the study, at midpoint of the study and at the end of the study by guided ultrasonography. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition | ||
| 正式标题 ICMJE | The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition | ||
| 简要概况 | The current study will compare the effectiveness as well as the safety of Itopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 2019 | ||
| 预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal 5. Exclusion Criteria: - Patients who met the following criteria were excluded: - Age less than 18 years or more than 60 years. - Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease. - Clinically significant hepatic dysfunction. (>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase) - Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks. - Patients with arrhythmia or atrioventricular blocks. - Any condition or comorbid disease that might interfere with gastric emptying such as diabetes. - Patients with head injuries. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Egypt | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Eman Mohamed El Mokadem，Future University in Egypt | ||
| 研究赞助商 ICMJE | Ain Shams University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Future University in Egypt | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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