- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03698292
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
Conditions
Intervention / Treatment
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
- Name: Eman Elmokadem, MSc.
- Phone Number: 01006242110
- Email: emy_101_@hotmail.com
Study Contact Backup
- Name: Maha Gameel, MD
- Phone Number: 01227342966
- Email: mahagamil@hotmail.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Kasr Al Ainy Hospital
-
Contact:
- Maha Hanna, MD
- Phone Number: 01227342966
- Email: mahagamil@hotmail.com
-
-
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.
Sponsor
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.
General Publications
- Gholipour Baradari A, Alipour A, Firouzian A, Moarab L, Emami Zeydi A. A Double-Blind Randomized Clinical Trial Comparing the Effect of Neostigmine and Metoclopramide on Gastric Residual Volume of Mechanically Ventilated ICU Patients. Acta Inform Med. 2016 Dec;24(6):385-389. doi: 10.5455/aim.2016.24.385-389.
- Gomes PC, Caporossi C, Aguilar-Nascimento JE, Silva AM, Araujo VM. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers. Arq Gastroenterol. 2017 Jan-Mar;54(1):33-36. doi: 10.1590/S0004-2803.2017v54n1-06.
- Elmokadem EM, El Borolossy RM, Bassiouny AM, Hanna MG, Darweesh EAG, Sabri NA. The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study. BMC Gastroenterol. 2021 Mar 19;21(1):126. doi: 10.1186/s12876-021-01712-w.
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Critical Illness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dopamine Agents
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Metoclopramide
Other Study ID Numbers
- 67 (Desicion number)
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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