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

Enteral Feeding Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496179
• Other study ID #: Future University in Egypt
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 30, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 15, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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, ?-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.

Related Conditions & MeSH terms

• Enteral Feeding Intolerance

Intervention

Drug:
• Prucalopride
Prokinetic
• Metoclopramide
Prokinetic

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric residual volume	Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume	7 days
Secondary	Determining the adequacy of enteral nutrition:	Enteral nutrition volume ratio	7 days
Secondary	Incidence of infectious complications.	C reactive protein	one month
Secondary	Length of ICU stay	duration of stay in intensive care unit	3 months
Secondary	Adverse drug events	occurence of adverse drug events	7 days