Enteral erythromycin versus intravenous metoclopramide for treatment of feeding intolerance in critically ill patients

Phase 3

• Conditions: Feeding intolerance in critically ill patients; Feeding intolerance, Critically ill

• Registration Number: TCTR20240626004
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-26
• Last Update Posted: 19 August 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Age 18 years old or older.
2. Critically ill patient which consist of
a. Patient admitted to Intensive care unit
b. Patient admitted to general medicine ward receiving ventilatory support by ventilator or vasopressor/ inotropes
3.The gastric residual volume measured after feeding initiation for more than 6 hours is 200 mL or greater.
4.The attending physician dosen't have other explanation for increased gastric residual volume.
5.The attending physician considers the necessity of using prokinetic drugs.
6.The patient or authorized representative consents to participate in the trial and signs the consent form.

Exclusion Criteria

1. Administration of any prokinetic drugs within the previous 24 hours
2. Known allergy to metoclopramide or macrolide antibiotics
3. Recent abdominal surgery within 6 weeks prior to the enrollment in the trial
4. Past history of esophagus and stomach surgery
5. Suspected bowel obstruction or perforation
6. Evidence of liver dysfunction
a. Transaminase levels increased to more than twice the upper limit of normal.
b. Prothrombin time increased to more than twice the upper limit of normal.
c. more than three times elevation above the upper limit of normal of Total bilirubin
7. Administration of drug known to have interaction with the study drug, such as carbamazepine, warfarin, theophylline, and digoxin.
8. History of ventricular arrhythmia or QT interval prolongation more than 480 ms fon a 12-lead electrocardiogram.
9. Diagnosed with myasthenia gravis
10. Pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful feeding within 48 hours Within 48 hours after administration of medication according to treament arm Measure gastric residual volume every 6 hours before each feeding session