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Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Phase 3UnknownNCT04190173
Prince of Songkla University62 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

62

Conditions

Paralytic IleusCritically Ill

Interventions

PrucaloprideDRUG

1-2 mg once daily enteral feeding for 5 consecutive days

PlaceboDRUG

1/2-1 tablet once daily enteral feeding for 5 consecutive days

Eligibility

Sex: ALLMin age: 18 Years
Medical Language ↔ Plain English
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

Locations (1)

Faculty of Medicine, Prince of Songkla University

Songkhla, Thailand

RECRUITING

Outcomes

Primary Outcomes

Change of maximum bowel diameter from baseline at 24 hours

measure on plain abdominal radiography by blinded radiologist

Time frame: after first dose intervention to next 24 hours

Change of maximum bowel diameter from baseline at 48 hours

measure on plain abdominal radiography by blinded radiologist

Time frame: after first dose intervention to next 48 hours

Change of maximum bowel diameter from baseline at 72 hours

measure on plain abdominal radiography by blinded radiologist

Time frame: after first dose intervention to next 72 hours

Change of maximum bowel diameter from baseline at 96 hours

measure on plain abdominal radiography by blinded radiologist

Time frame: after first dose intervention to next 96 hours

Change of maximum bowel diameter from baseline at 120 hours

measure on plain abdominal radiography by blinded radiologist

Time frame: after first dose intervention to next 120 hours

Secondary Outcomes

change of abdominal circumference from baseline at 24 hours

measured at umbilical level

Time frame: after first dose intervention to next 24 hours

change of abdominal circumference from baseline at 48 hours

measured at umbilical level

Time frame: after first dose intervention to next 48 hours

change of abdominal circumference from baseline at 72 hours

measured at umbilical level

Time frame: after first dose intervention to next 72 hours

change of abdominal circumference from baseline at 96 hours

measured at umbilical level

Time frame: after first dose intervention to next 96 hours

change of abdominal circumference from baseline at 120 hours

measured at umbilical level

Time frame: after first dose intervention to next 120 hours

Central Contacts

Panu Wetwittayakhlang, Dr.

CONTACT

66867725277wet.panu@gmail.com
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.