Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition

Ain Shams University

Status: Unknown

Conditions: Critically-ill Patients

Treatments: Drug: Metoclopramide 10mg; Drug: Itopride

Study type: Interventional

Funder types: Other

Identifiers

NCT03698292

67

Details and patient eligibility

About

The current study will compare the effectiveness as well as the safety of Itopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.

Enrollment: 60 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) 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 5.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

First group

Active Comparator group

Description:

Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days

Treatment:

Drug: Metoclopramide 10mg

Second Group

Active Comparator group

Description:

Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days

Treatment:

Drug: Itopride