Back to resultsItopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
Primary Purpose
Critically-ill Patients
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Itopride
Metoclopramide 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Critically-ill Patients
Eligibility Criteria
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.
Sites / Locations
- Kasr Al Ainy HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
First group
Second Group
Arm Description
Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days
Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days
Outcomes
Primary Outcome Measures
Gastric Residual Volume
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
Determining the adequacy of enteral nutrition
By calculating the ratio between administered and prescribed feeds over 24 hours duration (Percentage of feed goal tolerated)
Length of ICU stay
Length of patients stay in the ICU will be assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03698292
Brief Title
Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
Official Title
The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically-ill Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First group
Arm Type
Active Comparator
Arm Description
Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days
Arm Title
Second Group
Arm Type
Active Comparator
Arm Description
Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Itopride
Intervention Description
Prokinetic Drug
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10mg
Intervention Description
Prokinetic Drug
Primary Outcome Measure Information:
Title
Gastric Residual Volume
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Determining the adequacy of enteral nutrition
Description
By calculating the ratio between administered and prescribed feeds over 24 hours duration (Percentage of feed goal tolerated)
Time Frame
24 hours
Title
Length of ICU stay
Description
Length of patients stay in the ICU will be assessed
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Elmokadem, MSc.
Phone
01006242110
Email
emy_101_@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Gameel, MD
Phone
01227342966
Email
mahagamil@hotmail.com
Facility Information:
Facility Name
Kasr Al Ainy Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha Hanna, MD
Phone
01227342966
Email
mahagamil@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28077899
Citation
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.
Results Reference
background
PubMed Identifier
28079236
Citation
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.
Results Reference
background
PubMed Identifier
33740892
Citation
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.
Results Reference
derived
Learn more about this trial
Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
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