跳至主要内容
临床试验/NCT05496179
NCT05496179已完成1 期

The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年8月30日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients will receive prucalopride (2 mg) once daily for 7 days.

干预措施: Prucalopride (Drug)

Metoclopramide

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Mohamed El Mokadem

Lecturer of Clinical Pharmacy

Ain Shams University

研究点 (1)

Loading locations...

相似试验