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
- Conditions
- feeding intolerancemechanically ventilated patientprokineticfeeding intolerancemechanically ventilated patientserythromycin estolategastric residual volume
- Registration Number
- TCTR20171004004
- Lead Sponsor
- Siam University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % successful feeding at 48 hours 48 hours Total calories
- Secondary Outcome Measures
Name Time Method % 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