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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05496179
• Collaborator: Future University in Egypt (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 16.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enteral Feeding Intolerance	Drug: Prucalopride; Drug: Metoclopramide	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients
• Actual Study Start Date: Mar 7, 2022
• Actual Primary Completion Date: Jul 10, 2022
• Actual Study Completion Date: Jul 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prucalopride Patients will receive prucalopride (2 mg) once daily for 7 days.	Drug: Prucalopride; Prokinetic; Other Names: Resolor
Active Comparator: Metoclopramide Patients will receive metoclopramide (10 mg) three times daily for 7 days.	Drug: Metoclopramide; Prokinetic; Other Names: Primperan

Outcome Measures

Primary Outcome Measures

1. Gastric residual volume [7 days]

   Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume

Secondary Outcome Measures

1. Determining the adequacy of enteral nutrition: [7 days]

   Enteral nutrition volume ratio

2. Incidence of infectious complications. [one month]

   C reactive protein

3. Length of ICU stay [3 months]

   duration of stay in intensive care unit

4. Adverse drug events [7 days]

   occurence of adverse drug events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Al Ainy Hospital	Cairo		Egypt	11865

Sponsors and Collaborators

• Ain Shams University
• Future University in Egypt

Investigators

• Principal Investigator: Eman Elmokadem, PhD, Future University in Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Mohamed El Mokadem, Lecturer of Clinical Pharmacy, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05496179
• Other Study ID Numbers: Future University in Egypt
• First Posted: Aug 11, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metoclopramide; Prucalopride

Study Results

No Results Posted as of Aug 12, 2022