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

Prince of Songkla University

Status and phase: Unknown; Phase 3

Conditions: Paralytic Ileus; Critically Ill

Treatments: Drug: Placebo; Drug: Prucalopride

Study type: Interventional

Funder types: Other

Identifiers

NCT04190173

59-394-14-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Prucalopride

Experimental group

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

Treatment:

Drug: Prucalopride

Placebo

Placebo Comparator group

Description:

Placebo tablet to mimic Prucalopride made by starch

Treatment:

Drug: Placebo