NCT03698292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

October 4, 2018

Last Update Submit

October 4, 2018

Conditions

Critically-ill Patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Secondary Outcomes (2)

  • Determining the adequacy of enteral nutrition

    24 hours

  • Length of ICU stay

    3 months

Study Arms (2)

First group

ACTIVE COMPARATOR

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

Drug: Metoclopramide 10mg

Second Group

ACTIVE COMPARATOR

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

Drug: Itopride

Interventions

ItoprideDRUG

Prokinetic Drug

Second Group
Metoclopramide 10mgDRUG

Prokinetic Drug

First group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy Hospital

Cairo, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28077899BACKGROUND

  • 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.

    PMID: 28079236BACKGROUND

  • 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.

    PMID: 33740892DERIVED

MeSH Terms

Interventions

itoprideMetoclopramide

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Central Study Contacts

Eman Elmokadem, MSc.

CONTACT

01006242110emy_101_@hotmail.com

Maha Gameel, MD

CONTACT

01227342966mahagamil@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 5, 2018

Study Start

October 1, 2018

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

EG(1)