The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Gastric residual volume
研究概览
简要总结
to compare the effectiveness as well as the safety of prucalopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.
详细描述
Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbidly malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older 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
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
Prucalopride
Patients will receive prucalopride (2 mg) once daily for 7 days.
干预措施: Prucalopride (Drug)
Metoclopramide
Patients will receive metoclopramide (10 mg) three times daily for 7 days.
干预措施: Metoclopramide (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 residual volume
次要结局
- Determining the adequacy of enteral nutrition:(7 days)
- Incidence of infectious complications.(one month)
- Length of ICU stay(3 months)
- Adverse drug events(7 days)
研究者
Eman Mohamed El Mokadem
Lecturer of Clinical Pharmacy
Ain Shams University
