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Efficacy and Safety of Enteral Erythromycin Estolate in Combination with Intravenous Metoclopramide versus Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients with Enteral Feeding Intolerance: A Randomized Pilot Study

Efficacy and Safety of Enteral Erythromycin Estolate in Combination with Intravenous Metoclopramide versus Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients with Enteral Feeding Intolerance: A Randomized Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171004004
Enrollment
30
Registered
2017-10-04
Start date
2018-02-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

feeding intolerance mechanically ventilated patient prokinetic feeding intolerance mechanically ventilated patients erythromycin estolate gastric residual volume

Interventions

Erythromycin estolate 250 mg (10 mL) every 6 hours combination with metoclopramide 10 mg IV every 6&#45
8 hours,Placebo suspension 10 mL every 6 hours combination with metoclopramide 10 mg IV every 6&#45
8 hours
Experimental Drug,Active Comparator Drug
Intervention group,Control group

Sponsors

Siam University
Lead Sponsor
Faculty of Pharmaceutical Sciences&#44
Collaborator
Prince of Songkla University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Mechanically ventilated patients who had feeding intolerance, defined as GRV greater than or equal to 250 mL during receive either continuous or intermittent enteral feeding or GRV greater than or equal to 150 mL concomitant with vomiting, regurgitation or abdominal distension.

Exclusion criteria

Exclusion criteria: The patients who 1. received any prokinetics drugs within the past 24 hours 2. have a history of allergic to metoclopramide and/or macrolide antibiotics 3. required pharmacological treatment for seizure 4. have hemodynamically unstable or any cardiac arrhythmia or prolonged QTc > 480 msec. on a 12-lead ECG 5. was diagnosed with acute CNS infection 6. was diagnosed with acute severe brain injury from any causes 7. have hyperbilirubinemia 8. currently received carbamazepine, digoxin, warfarin, haloperidol or perphenazine 9. have undergone small bowel or large bowel surgery within 6 weeks before study 10. have a history of esophagectomy or partial/total gastrectomy at any time before study 11. was diagnosed with myasthenia gravis or pheochromocytoma 12. was suspected or confirmed bowel obstruction or perforation, 13. were expected to be extubated within 48 hours 14. Declined to participate

Design outcomes

Primary

MeasureTime frame
% successful feeding at 48 hours 48 hours Total calories

Secondary

MeasureTime frame
% successful feeding day 1-7 actual total calories ,% administered/ targeted calorie requirement ratio day 1-7 gastric residual volume,Length of hospital stay (LOS) until discharge The number of hospitalization days,Hospital mortality rate until discharge mortality rate,incidence of pneumonia day 1-7 incidence of pneumonia,incidence of arrhythmia day1-7 incidence of pneumonia,incidence of diarrhea day1-7 incidence of diarrhea,Gastric Residual Volume (GRV) day 1-7 total mean GRV /day,Total calories day 1-7 total calories/day

Countries

Thailand

Contacts

Public ContactTaniya Charoensareerat

Siam University

taniya.cha@siam.edu090-6488732

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026