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

Ain Shams University

Status and phase

Not yet enrolling

Phase 3

Conditions

Enteral Feeding Intolerance

Treatments

Drug: Mosapride Citrate Tablets

Drug: Metoclopramide 10mg

Study type

Interventional

Funder types

Other

Identifiers

NCT06826443

HM000185

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.