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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Eman Mohamed El Mokadem，Future University in Egypt

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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)
Length of ICU stay[ Time Frame: 3 months ]
Length of patients stay in the ICU will be assessed

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Itopride
Prokinetic Drug
Drug: Metoclopramide 10mg
Prokinetic Drug

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Egypt

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Eman Mohamed El Mokadem，Future University in Egypt

Study Sponsor ^ICMJE

Ain Shams University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Future University in Egypt

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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