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

October 4, 2018 updated by: Eman Mohamed El Mokadem, Ain Shams University

The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition

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.

Study Overview

Status

Unknown

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cairo, Egypt
        • Recruiting
        • Kasr Al Ainy Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: First group
Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days
Prokinetic Drug
Active Comparator: Second Group
Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days
Prokinetic Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Residual Volume
Time Frame: 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.

7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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