Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Critically Ill Clinical Trial

— EPRUCIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190173
• Other study ID #: 59-394-14-1
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2017
• Est. completion date: February 15, 2020

Study information

• Verified date: February 2020
• Source: Prince of Songkla University
• Contact: Panu Wetwittayakhlang, Dr.
• Phone: 66867725277
• Email: wet.panu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: February 15, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• Medical patients with APACHE II score >= 15

• Paralytic ileus: small bowel diameter >= 4 cm or large bowel diameter >= 6 cm

Exclusion:

• no current prokinetic use

• Severe peritonitis or bowel inflammation

• ESRD needed hemodialysis

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Ileus
• Intestinal Pseudo-Obstruction
• Paralytic Ileus

Intervention

Drug:
• Prucalopride
1-2 mg once daily enteral feeding for 5 consecutive days
• Placebo
1/2-1 tablet once daily enteral feeding for 5 consecutive days

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of maximum bowel diameter from baseline at 24 hours	measure on plain abdominal radiography by blinded radiologist	after first dose intervention to next 24 hours
Primary	Change of maximum bowel diameter from baseline at 48 hours	measure on plain abdominal radiography by blinded radiologist	after first dose intervention to next 48 hours
Primary	Change of maximum bowel diameter from baseline at 72 hours	measure on plain abdominal radiography by blinded radiologist	after first dose intervention to next 72 hours
Primary	Change of maximum bowel diameter from baseline at 96 hours	measure on plain abdominal radiography by blinded radiologist	after first dose intervention to next 96 hours
Primary	Change of maximum bowel diameter from baseline at 120 hours	measure on plain abdominal radiography by blinded radiologist	after first dose intervention to next 120 hours
Secondary	change of abdominal circumference from baseline at 24 hours	measured at umbilical level	after first dose intervention to next 24 hours
Secondary	change of abdominal circumference from baseline at 48 hours	measured at umbilical level	after first dose intervention to next 48 hours
Secondary	change of abdominal circumference from baseline at 72 hours	measured at umbilical level	after first dose intervention to next 72 hours
Secondary	change of abdominal circumference from baseline at 96 hours	measured at umbilical level	after first dose intervention to next 96 hours
Secondary	change of abdominal circumference from baseline at 120 hours	measured at umbilical level	after first dose intervention to next 120 hours