Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Phase 3

• Conditions: Paralytic Ileus; Critically Ill
• Interventions: Drug: Placebo; Drug: Prucalopride

• Registration Number: NCT04190173
• Lead Sponsor: Prince of Songkla University

Brief 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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-09
• Primary Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06
• Study Completion: 2020-02-15

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet to mimic Prucalopride made by starch
Prucalopride	Prucalopride	Prucalopride (Trade name: Resolor) 2 mg oral or tube feeding once daily 5 consecutive days Decrease dose to 1 mg once daily in patient with end stage kidney disease or Cirrhosis Child Pugh C

Primary Outcome Measures

Name	Time	Method
Change of maximum bowel diameter from baseline at 120 hours	after first dose intervention to next 120 hours	measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 24 hours	after first dose intervention to next 24 hours	measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 96 hours	after first dose intervention to next 96 hours	measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 48 hours	after first dose intervention to next 48 hours	measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 72 hours	after first dose intervention to next 72 hours	measure on plain abdominal radiography by blinded radiologist

Secondary Outcome Measures

Name	Time	Method
change of abdominal circumference from baseline at 96 hours	after first dose intervention to next 96 hours	measured at umbilical level
change of abdominal circumference from baseline at 24 hours	after first dose intervention to next 24 hours	measured at umbilical level
change of abdominal circumference from baseline at 72 hours	after first dose intervention to next 72 hours	measured at umbilical level
change of abdominal circumference from baseline at 120 hours	after first dose intervention to next 120 hours	measured at umbilical level
change of abdominal circumference from baseline at 48 hours	after first dose intervention to next 48 hours	measured at umbilical level

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Songkhla, Thailand