The efficacy of combination therapy of metoclopramide and prucalopride versus placebo in reducing gastric residual volume in critically ill patients: A randomized controlled trial

Phase 4

• Conditions: Feeding intoleranceCritically ill patients; Prucalopride; Metoclopramide; Feeding intolerance; Critically ill patients

• Registration Number: TCTR20220503004
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-03
• Study Completion: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 62

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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