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NOT YET RECRUITING
NCT07031479
PHASE4

Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume

Sponsor: Chulalongkorn University

View on ClinicalTrials.gov

Summary

A prospective randomized controlled trial included 86 patients in medicine ward who were diagnosed with feeding intolerance, defined as having a gastric residual volume greater than 200 ml. The patients were randomly assigned to two treatment groups: one receiving enteral metoclopramide and the other receiving intravenous metoclopramide. The primary outcome was the gastric residual volume at 72 hours after treatment. The secondary outcome was gastric residual volume at 24 hours and 7 days after treatment, administered-to-prescribed volume at 72 hours after treatment, the administered-to-target energy ratio and the administered-to-target protein ratio at 96 hours after treatment, the nutrition status evaluated by the Nutrition Alert Form at 7 days after treatment, incidence of adverse events (arrhythmia, pneumonia, diarrhea, vomiting, aspiration), length of hospital stay, ICU length of stay and in-hospital mortality.

Official title: Efficacy of Enteral Itopride Versus Intravenous Metoclopramide in Hospitalized Medicine Patients With Feeding Intolerance Causing by High Gastric Residual Volume: a Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2025-07-01

Completion Date

2026-09-30

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

DRUG

Itopride HCI 50 mg

Enteral Itopride 50 mg enterally tid ac

DRUG

Metoclopramide 10 mg ampoule

Intravenous Metoclopramide (10 mg IV q 6 hours) CrCl 15-60 ml/min: Metoclopramide 5 mg IV q 6 hours CrCl \<15 ml/min: Metoclopramide 5 mg IV q 12 hours Hepatic impairment/ cirrhosis: Metoclopramide 5 mg IV q 6 hours