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

Phase 1

Completed

• Conditions: Enteral Feeding Intolerance
• Interventions: Drug: Metoclopramide; Drug: Prucalopride

• Registration Number: NCT05496179
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-08-30
• Primary Completion: 2023-06-10
• Study Completion: 2023-07-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide	Metoclopramide	Patients will receive metoclopramide (10 mg) three times daily for 7 days.
Prucalopride	Prucalopride	Patients will receive prucalopride (2 mg) once daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Gastric residual volume	7 days	Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kasr Al Ainy Hospital; 🇪🇬 Cairo, Egypt