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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03698292

Enrollment

Registered

2018-10-05

Start date

2018-10-31

Completion date

2019-09-30

Last updated

2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically-ill Patients

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.

Interventions

DRUGItopride

Prokinetic Drug

DRUGMetoclopramide 10mg

Prokinetic Drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Gastric Residual Volume	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.

Secondary

Measure	Time frame	Description
Determining the adequacy of enteral nutrition	24 hours	By calculating the ratio between administered and prescribed feeds over 24 hours duration (Percentage of feed goal tolerated)
Length of ICU stay	3 months	Length of patients stay in the ICU will be assessed

Countries

Egypt

Contacts

Primary ContactEman Elmokadem, MSc.

emy_101_@hotmail.com01006242110

Backup ContactMaha Gameel, MD

mahagamil@hotmail.com01227342966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026