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EPRUCIL: Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Sponsor
Prince of Songkla University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04190173
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
31.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Consecutive enrolment parallel group in intervention group and placebo groupConsecutive enrolment parallel group in intervention group and placebo group
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The intervention was blinded to patients, nurse, investigators, and radiologist
Primary Purpose:
Treatment
Official Title:
Efficacy of Prucalopride in Critically Ill Patients With Paralytic Ileus; a Pilot Randomized Double-blind Controlled Trial
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Jan 30, 2020
Anticipated Study Completion Date :
Feb 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Prucalopride
1-2 mg once daily enteral feeding for 5 consecutive days
Other Names:
  • Resolor

    		•
    Placebo Comparator: Placebo

    Placebo tablet to mimic Prucalopride made by starch

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    Secondary Outcome Measures

    1. change of abdominal circumference from baseline at 24 hours [after first dose intervention to next 24 hours]

      measured at umbilical level

    2. change of abdominal circumference from baseline at 48 hours [after first dose intervention to next 48 hours]

      measured at umbilical level

    3. change of abdominal circumference from baseline at 72 hours [after first dose intervention to next 72 hours]

      measured at umbilical level

    4. change of abdominal circumference from baseline at 96 hours [after first dose intervention to next 96 hours]

      measured at umbilical level

    5. change of abdominal circumference from baseline at 120 hours [after first dose intervention to next 120 hours]

      measured at umbilical level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Prince of Songkla University Songkhla Thailand 90110

    Sponsors and Collaborators

    • Prince of Songkla University

    Investigators

    • Principal Investigator: Sawangpong Jandee, Dr., Faculty of Medicine, Prince of Songkla University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Panu Wetwittayakhlang, Principal investigator, Prince of Songkla University
    ClinicalTrials.gov Identifier:
    NCT04190173
    Other Study ID Numbers:
    • 59-394-14-1
    First Posted:
    Dec 9, 2019
    Last Update Posted:
    Feb 6, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Panu Wetwittayakhlang, Principal investigator, Prince of Songkla University
    Prokinetic
    Prucalopride
    Additional relevant MeSH terms:
    Ileus
    Intestinal Pseudo-Obstruction
    Critical Illness
    Prucalopride

    Study Results

    No Results Posted as of Feb 6, 2020