NCT04190173

Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Paralytic ileus is a common intestinal dysfunction in critically ill patients. There are still no established the effective medications except correcting the primary causes and prokinetics trial which limited in efficacy and potential adverse events.

Detailed description

Prucalopride, a highly selective 5-HT4 receptor agonist, accelerates gastrointestinal transit which may reduce severity of ileus. Furthermore, there is no report of serious cardiac and neurological side effects. We aim to evaluate the efficacy of prucalopride as a prokinetic of choice on paralytic ileus in critically ill patients.

Conditions

• Paralytic Ileus
• Critically Ill

Interventions

Type	Name	Description
DRUG	Prucalopride	1-2 mg once daily enteral feeding for 5 consecutive days
DRUG	Placebo	1/2-1 tablet once daily enteral feeding for 5 consecutive days

Timeline

• Start date: 2017-07-01
• Primary completion: 2020-01-30
• Completion: 2020-02-15
• First posted: 2019-12-09
• Last updated: 2020-02-06

Locations

1 site across 1 country: Thailand