Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

NCT04190173 | Unknown Phase 3 DMC

• 1 other identifier: 59-394-14-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Paralytic Ileus; Critically Ill

Keywords

Prokinetic; Prucalopride

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• change of abdominal circumference from baseline at 24 hours

  after first dose intervention to next 24 hours

• change of abdominal circumference from baseline at 48 hours

  after first dose intervention to next 48 hours

• change of abdominal circumference from baseline at 72 hours

  after first dose intervention to next 72 hours

• change of abdominal circumference from baseline at 96 hours

  after first dose intervention to next 96 hours

• change of abdominal circumference from baseline at 120 hours

  after first dose intervention to next 120 hours

Study Arms (2)

Prucalopride

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo tablet to mimic Prucalopride made by starch

Drug: Placebo

Interventions

Prucalopride DRUG

1-2 mg once daily enteral feeding for 5 consecutive days

Also known as: Resolor

Prucalopride

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical patients with APACHE II score \>= 15
• Paralytic ileus: small bowel diameter \>= 4 cm or large bowel diameter \>= 6 cm

You may not qualify if:

• no current prokinetic use
• Severe peritonitis or bowel inflammation
• ESRD needed hemodialysis

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction; Critical Illness

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sawangpong Jandee, Dr.

  Faculty of Medicine, Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panu Wetwittayakhlang, Dr.

CONTACT

66867725277; wet.panu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention was blinded to patients, nurse, investigators, and radiologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Consecutive enrolment parallel group in intervention group and placebo group

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 9, 2019
• Study Start: July 1, 2017
• Primary Completion: January 30, 2020
• Study Completion: February 15, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)