NCT03698292Unknown不适用
The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastric Residual Volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
First group
Active Comparator
Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days
干预措施: Metoclopramide 10mg (Drug)
Second Group
Active Comparator
Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days
干预措施: Itopride (Drug)
结局指标
主要结局
Gastric Residual Volume
时间窗: 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.
次要结局
- Length of ICU stay(3 months)
- Determining the adequacy of enteral nutrition(24 hours)
研究者
Eman Mohamed El Mokadem
Assistant Lecturer
Future University in Egypt
研究点 (1)
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