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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Enteral Feeding Intolerance

Intervention / Treatment
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* Drug: Prucalopride
* Drug: Metoclopramide


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prucalopride<br>Patients will receive prucalopride (2 mg) once daily for 7 days. | Drug: Prucalopride<br>* Prokinetic<br>* Other names: Resolor;|
| Active Comparator: Metoclopramide<br>Patients will receive metoclopramide (10 mg) three times daily for 7 days. | Drug: Metoclopramide<br>* Prokinetic<br>* Other names: Primperan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric residual volume | Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the adequacy of enteral nutrition: | Enteral nutrition volume ratio | 7 days | 
| Incidence of infectious complications. | C reactive protein | one month | 
| Length of ICU stay | duration of stay in intensive care unit | 3 months | 
| Adverse drug events | occurence of adverse drug events | 7 days |