A Comparative Evaluation of Mosapride Versus Metoclopramide for Enteral Feeding Intolerance in Critically Ill Patients

NCT ID: NCT06826443

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-05-31

Brief Summary

Caring for critically ill patients in an intensive care unit (ICU) is considered a standard of care. According to the Society of Critical Care Medicine (SCCM), as a function of the complex nature of the care provided in the ICU, the ideal method to provide support to the critically ill involves the participation of a multi-professional staff.

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 premorbid 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.

Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patients has demonstrated the importance of the use of prokinetic drugs to improve tolerance to gastric feeding in critically ill patients and achieve earlier discharge.

Prokinetic drugs act by promoting gastric motility, increase gastric emptying, prevent the retention and reflux of gastric contents and thus provide symptomatic relief.

Most of the prokinetic drugs are efficacious with prokinetic activity but the matter of major concern is their side effect profile. The most commonly used agent is metoclopramide. Although it is the most commonly used prokinetic to treat delayed gastric emptying and facilitate early enteral feeding, adverse complications limit its use including tachyphylaxis, tardive dyskinesia on long term use and QT prolongation predisposing to cardiac arrhythmias. Several drug targets have been identified to develop new promotility agents and several new medications are under investigation to overcome the side effects caused by most of the prokinetics .

Mosapride is another available prokinetic agent that enhances gastric motility through serotonin receptor agonism; resulting in prokinetic effects. It accelerates gastric emptying, improves gastric tension and sensitivity, and has anti-emetic action.

The aim of the current study is to compare the effectiveness as well as the safety of Mosapride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.

Conditions

Enteral Feeding Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mosapride citrate group

These patients will receive Mosapride citrate (5 mg) three times daily for 7 days.

Group Type: ACTIVE_COMPARATOR

Mosapride Citrate Tablets

Intervention Type: DRUG

Prokinetic Drug

Metoclopramide

These patients will receive metoclopramide (10 mg) three times daily for 7 days.

Group Type: ACTIVE_COMPARATOR

Metoclopramide 10mg

Intervention Type: DRUG

Prokinetic Drug

Interventions

Mosapride Citrate Tablets

Prokinetic Drug

Intervention Type: DRUG

Metoclopramide 10mg

Prokinetic Drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aging between 18 and 60 years (of both sexes)
• Patients admitted to the ICU and are expected to stay in the ICU for not less than 7 days
• Patients prescribed enteral feeding.

Exclusion Criteria

The following patients are

• Age less than 18 years or more than 60 years.
• Patients who had previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.
• Patients who are clinically significant hepatic dysfunction. (>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)
• Patients who are on regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.
• Patients with arrhythmia or atrioventricular blocks.
• Patients with any condition or comorbid disease that might interfere with gastric emptying such as diabetes.
• Patients with head injuries.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mohamed El Mokadem

Lecturer of Pharmacy Practice and Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Matarya Teaching Hospital

Cairo, , Egypt

Countries

Egypt

Facility Contacts

Amir Iskander Fellow in the Critical Care Department - Matareya Teaching Hos

Role: primary

amireskanderhanna@gmail.com

+201227933624

References

Charoensareerat T, Bhurayanontachai R, Sitaruno S, Navasakulpong A, Boonpeng A, Lerkiatbundit S, Pattharachayakul S. Efficacy and Safety of Enteral Erythromycin Estolate in Combination With Intravenous Metoclopramide vs Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients With Enteral Feeding Intolerance: A Randomized, Double-Blind, Controlled Pilot Study. JPEN J Parenter Enteral Nutr. 2021 Aug;45(6):1309-1318. doi: 10.1002/jpen.2013. Epub 2020 Oct 2.

Reference Type: BACKGROUND

PMID: 32895971 (View on PubMed)

Other Identifiers

HM000185

Identifier Type: -

Identifier Source: org_study_id