NCT05496179

Brief Summary

to compare the effectiveness as well as the safety of prucalopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

August 9, 2022

Last Update Submit

April 11, 2024

Conditions

Enteral Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • Gastric residual volume

    Gastric residual volume as a surrogate to gastric emptying by means of gastric residual volume

    7 days

Secondary Outcomes (4)

  • Determining the adequacy of enteral nutrition:

    7 days

  • Incidence of infectious complications.

    one month

  • Length of ICU stay

    3 months

  • Adverse drug events

    7 days

Study Arms (2)

Prucalopride

ACTIVE COMPARATOR

Patients will receive prucalopride (2 mg) once daily for 7 days.

Drug: Prucalopride

Metoclopramide

ACTIVE COMPARATOR

Patients will receive metoclopramide (10 mg) three times daily for 7 days.

Drug: Metoclopramide

Interventions

PrucaloprideDRUG

Prokinetic

Also known as: Resolor
Prucalopride
MetoclopramideDRUG

Prokinetic

Also known as: Primperan
Metoclopramide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal

You may not qualify if:

  • Patients who met the following criteria were excluded:
  • Age less than 18 years or more than 60 years.
  • Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.
  • Clinically significant hepatic dysfunction. (\>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)
  • Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.
  • Patients with arrhythmia or atrioventricular blocks.
  • Any condition or comorbid disease that might interfere with gastric emptying such as diabetes.
  • Patients with head injuries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy Hospital

Cairo, 11865, Egypt

Location

Related Publications (1)

  • Elmokadem EM, Abou El Fadl DK, Eissa N, Alnassar NA, Bassiouny AM, Hanna Samy AE, El Said NO. Comparison of enteral prucalopride versus intravenous metoclopramide for feeding intolerance in patients with critical illness: a randomized double-blinded study. Front Pharmacol. 2024 Nov 8;15:1413246. doi: 10.3389/fphar.2024.1413246. eCollection 2024.

    PMID: 39584139DERIVED

MeSH Terms

Interventions

prucaloprideMetoclopramide

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Eman Elmokadem, PhD

    Future University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

August 30, 2022

Primary Completion

June 10, 2023

Study Completion

July 15, 2023

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)