Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-02-15

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.

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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.

Conditions

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Paralytic Ileus Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Consecutive enrolment parallel group in intervention group and placebo group

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The intervention was blinded to patients, nurse, investigators, and radiologist

Study Groups

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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

Group Type EXPERIMENTAL

Prucalopride

Intervention Type DRUG

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

Placebo

Placebo tablet to mimic Prucalopride made by starch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Prucalopride

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Resolor

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No