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

Not Applicable

• Conditions: Critically-ill Patients
• Interventions: Drug: Metoclopramide 10mg; Drug: Itopride

• Registration Number: NCT03698292
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10
• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Last Update Submitted: 2018-10-04
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-05
• Primary Completion: 2019-06
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First group	Metoclopramide 10mg	Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days
Second Group	Itopride	Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days

Primary Outcome Measures

Name	Time	Method
Gastric Residual Volume	7 days	Gastric residual volume as a surrogate to gastric emptying by means of gastric ultrasound.; of the study, at midpoint of the study and at the end of the study by guided ultrasonography.

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	3 months	Length of patients stay in the ICU will be assessed
Determining the adequacy of enteral nutrition	24 hours	By calculating the ratio between administered and prescribed feeds over 24 hours duration (Percentage of feed goal tolerated)

Trial Locations

Locations (1)

Kasr Al Ainy Hospital; 🇪🇬 Cairo, Egypt