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

NCT ID: NCT03698292

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Critically-ill Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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First group

Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days

Group Type ACTIVE_COMPARATOR

Metoclopramide 10mg

Intervention Type DRUG

Prokinetic Drug

Second Group

Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days

Group Type ACTIVE_COMPARATOR

Itopride

Intervention Type DRUG

Prokinetic Drug

Interventions

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Itopride

Prokinetic Drug

Intervention Type DRUG

Metoclopramide 10mg

Prokinetic Drug

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Eman Mohamed El Mokadem

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Al Ainy Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman Elmokadem, MSc.

Role: CONTACT

01006242110

Maha Gameel, MD

Role: CONTACT

01227342966

Facility Contacts

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Maha Hanna, MD

Role: primary

01227342966

References

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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.

Reference Type BACKGROUND
PMID: 28077899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28079236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33740892 (View on PubMed)

Other Identifiers

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67

Identifier Type: -

Identifier Source: org_study_id

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