Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Paralytic Ileus, Critically Ill

Intervention / Treatment
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* Drug: Prucalopride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Consecutive enrolment parallel group in intervention group and placebo group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prucalopride<br>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 | Drug: Prucalopride<br>* 1-2 mg once daily enteral feeding for 5 consecutive days<br>* Other names: Resolor;|
| Placebo Comparator: Placebo<br>Placebo tablet to mimic Prucalopride made by starch | Drug: Placebo<br>* 1/2-1 tablet once daily enteral feeding for 5 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of abdominal circumference from baseline at 24 hours | measured at umbilical level | after first dose intervention to next 24 hours | 
| change of abdominal circumference from baseline at 48 hours | measured at umbilical level | after first dose intervention to next 48 hours | 
| change of abdominal circumference from baseline at 72 hours | measured at umbilical level | after first dose intervention to next 72 hours | 
| change of abdominal circumference from baseline at 96 hours | measured at umbilical level | after first dose intervention to next 96 hours | 
| change of abdominal circumference from baseline at 120 hours | measured at umbilical level | after first dose intervention to next 120 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prokinetic, Prucalopride