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Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus (EPRUCIL)

Primary Purpose

Paralytic Ileus, Critically Ill

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Prucalopride
Placebo
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paralytic Ileus focused on measuring Prokinetic, Prucalopride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Prince of Songkla UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prucalopride

Placebo

Arm Description

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

Placebo tablet to mimic Prucalopride made by starch

Outcomes

Primary Outcome Measures

Change of maximum bowel diameter from baseline at 24 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 48 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 72 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 96 hours
measure on plain abdominal radiography by blinded radiologist
Change of maximum bowel diameter from baseline at 120 hours
measure on plain abdominal radiography by blinded radiologist

Secondary Outcome Measures

change of abdominal circumference from baseline at 24 hours
measured at umbilical level
change of abdominal circumference from baseline at 48 hours
measured at umbilical level
change of abdominal circumference from baseline at 72 hours
measured at umbilical level
change of abdominal circumference from baseline at 96 hours
measured at umbilical level
change of abdominal circumference from baseline at 120 hours
measured at umbilical level

Full Information

First Posted
December 2, 2019
Last Updated
February 5, 2020
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT04190173
Brief Title
Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus
Acronym
EPRUCIL
Official Title
Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
February 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralytic Ileus, Critically Ill
Keywords
Prokinetic, Prucalopride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Consecutive enrolment parallel group in intervention group and placebo group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The intervention was blinded to patients, nurse, investigators, and radiologist
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prucalopride
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet to mimic Prucalopride made by starch
Intervention Type
Drug
Intervention Name(s)
Prucalopride
Other Intervention Name(s)
Resolor
Intervention Description
1-2 mg once daily enteral feeding for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1/2-1 tablet once daily enteral feeding for 5 consecutive days
Primary Outcome Measure Information:
Title
Change of maximum bowel diameter from baseline at 24 hours
Description
measure on plain abdominal radiography by blinded radiologist
Time Frame
after first dose intervention to next 24 hours
Title
Change of maximum bowel diameter from baseline at 48 hours
Description
measure on plain abdominal radiography by blinded radiologist
Time Frame
after first dose intervention to next 48 hours
Title
Change of maximum bowel diameter from baseline at 72 hours
Description
measure on plain abdominal radiography by blinded radiologist
Time Frame
after first dose intervention to next 72 hours
Title
Change of maximum bowel diameter from baseline at 96 hours
Description
measure on plain abdominal radiography by blinded radiologist
Time Frame
after first dose intervention to next 96 hours
Title
Change of maximum bowel diameter from baseline at 120 hours
Description
measure on plain abdominal radiography by blinded radiologist
Time Frame
after first dose intervention to next 120 hours
Secondary Outcome Measure Information:
Title
change of abdominal circumference from baseline at 24 hours
Description
measured at umbilical level
Time Frame
after first dose intervention to next 24 hours
Title
change of abdominal circumference from baseline at 48 hours
Description
measured at umbilical level
Time Frame
after first dose intervention to next 48 hours
Title
change of abdominal circumference from baseline at 72 hours
Description
measured at umbilical level
Time Frame
after first dose intervention to next 72 hours
Title
change of abdominal circumference from baseline at 96 hours
Description
measured at umbilical level
Time Frame
after first dose intervention to next 96 hours
Title
change of abdominal circumference from baseline at 120 hours
Description
measured at umbilical level
Time Frame
after first dose intervention to next 120 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panu Wetwittayakhlang, Dr.
Phone
66867725277
Email
wet.panu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sawangpong Jandee, Dr.
Organizational Affiliation
Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panu Wetwittayakhlang, Dr.
Phone
66867725277
Email
wet.panu@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

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