Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190173
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Panu Wetwittayakhlang, Prince of Songkla University

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
Paralytic Ileus Critically Ill Drug: Prucalopride Drug: Placebo 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consecutive 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 : July 1, 2017
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : February 15, 2020


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 Name: 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




Primary Outcome Measures :
  1. Change of maximum bowel diameter from baseline at 24 hours [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: after first dose intervention to next 24 hours ]
    measured at umbilical level

  2. change of abdominal circumference from baseline at 48 hours [ Time Frame: after first dose intervention to next 48 hours ]
    measured at umbilical level

  3. change of abdominal circumference from baseline at 72 hours [ Time Frame: after first dose intervention to next 72 hours ]
    measured at umbilical level

  4. change of abdominal circumference from baseline at 96 hours [ Time Frame: after first dose intervention to next 96 hours ]
    measured at umbilical level

  5. change of abdominal circumference from baseline at 120 hours [ Time Frame: after first dose intervention to next 120 hours ]
    measured at umbilical level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190173


Contacts
Layout table for location contacts
Contact: Panu Wetwittayakhlang, Dr. 66867725277 wet.panu@gmail.com

Locations
Layout table for location information
Thailand
Faculty of Medicine, Prince of Songkla University Recruiting
Songkhla, Thailand, 90110
Contact: Panu Wetwittayakhlang, Dr.    66867725277    wet.panu@gmail.com   
Sponsors and Collaborators
Prince of Songkla University
Investigators
Layout table for investigator information
Principal Investigator: Sawangpong Jandee, Dr. Faculty of Medicine, Prince of Songkla University
Layout table for additonal information
Responsible Party: Panu Wetwittayakhlang, Principal investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT04190173    
Other Study ID Numbers: 59-394-14-1
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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, Prince of Songkla University:
Prokinetic
Prucalopride
Additional relevant MeSH terms:
Layout table for MeSH terms
Ileus
Intestinal Pseudo-Obstruction
Critical Illness
Disease Attributes
Pathologic Processes
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs