Clinical trial NCT04190173: Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus
Official title: Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Paralytic Ileus
Critically Ill
Keywords: Prokinetic
Prucalopride
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consecutive enrolment parallel group in intervention group and placebo group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of maximum bowel diameter from baseline at 24 hours
timeFrame: after first dose intervention to next 24 hours
measure: Change of maximum bowel diameter from baseline at 48 hours
timeFrame: after first dose intervention to next 48 hours
measure: Change of maximum bowel diameter from baseline at 72 hours
timeFrame: after first dose intervention to next 72 hours
measure: Change of maximum bowel diameter from baseline at 96 hours
timeFrame: after first dose intervention to next 96 hours
measure: Change of maximum bowel diameter from baseline at 120 hours
timeFrame: after first dose intervention to next 120 hours
Secondary outcomes:
measure: change of abdominal circumference from baseline at 24 hours
timeFrame: after first dose intervention to next 24 hours
measure: change of abdominal circumference from baseline at 48 hours
timeFrame: after first dose intervention to next 48 hours
measure: change of abdominal circumference from baseline at 72 hours
timeFrame: after first dose intervention to next 72 hours
measure: change of abdominal circumference from baseline at 96 hours
timeFrame: after first dose intervention to next 96 hours
measure: change of abdominal circumference from baseline at 120 hours
timeFrame: after first dose intervention to next 120 hours
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University
name: Sawangpong Jandee, Dr.
role: PRINCIPAL_INVESTIGATOR
References: