Feeding intolerance Critically ill patients Prucalopride Metoclopramide Feeding intolerance Critically ill patients
Conditions
Interventions
Prucalopride 2 mg via tube feeding once daily in combination with metoclopramide 10 mg intravenously every 8 hours,Metoclopramide 10 mg intravenously every 8 hours with a placebo tablet identical to p
Experimental Drug,Placebo Comparator Drug
Metoclopramide and prucalopride,Metoclopramide and placebo
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients in medical intensive care units and medical respiratory care units 2. Feeding intolerance, defined as GRV of 250 ml or more 3. Expected to be on tube feeding for at least 5 days (by their primary doctors)
Exclusion criteria
Exclusion criteria: 1. Receiving prokinetic drugs within the previous 24 hours 2. History of allergy to prucalopride or metoclopramide 3. Gastrointestinal bleeding, obstruction, or perforation 4. Hemodynamic instability at the time of enteral tube feeding initiation, defined as a mean arterial pressure of less than 50 mmHg or escalating doses of vasopressor or inotropic agents required to maintain a MAP value of more than 50 mmHg within 24 hours 5. Undergone major gastrointestinal surgery (laparotomy with part of gastrointestinal tract removed or repaired) within the previous 2 weeks 6. Severe inflammatory conditions of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, and toxic megacolon, or preexisting chronic diarrheal diseases 7. Underlying of known pheochromocytoma 8. QT prolongation on 12-lead ECG, defined by QTc of more than 440 ms in male and 460 ms in female 9. History of extrapyramidal symptoms 10. Presence of clinical refeeding syndrome 11. On gastrostomy tube 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean gastric residual volume Day 2 (24-48 hours) Manual aspiration of gastric contents using 50-ml syringe and record gastric residual volume 4-hourly | — |
Secondary
| Measure | Time frame |
|---|---|
| Administered/target calorie ratio 4-hourly Calorie ratio,Number of patients resolving from feeding intolerance Day 1-7 after treatment Number,Ventilator-associated pneumonia During admission Number,Symptoms of feeding intolerance Day 1-7 Symptoms of feeding intolerance,ICU length of stay During admission Days,Hospital length of stay During admission Days,30-day mortality 30 days Mortality rate,In-hospital mortality During admission Mortality rate | — |
Countries
Thailand
Contacts
Public ContactPimsiri Sripongpun
Faculty of Medicine, Prince of Songkla University
Outcome results
None listed