## Protocol Section
### Identification Module
**NCT ID:** NCT05496179

**Brief Title:** The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients

**Official Title:** The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients

#### Organization Study ID Info
**ID:** Future University in Egypt
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2023-07-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-10

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-30

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-08-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-09
**Study First Submit QC Date:** 2022-08-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Future University in Egypt

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Eman Mohamed El Mokadem

**Investigator Title:** Lecturer of Clinical Pharmacy

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbidly malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.

### Conditions Module

**Conditions:**

- Enteral Feeding Intolerance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 70

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Prucalopride

**Label:** Prucalopride

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Drug: Metoclopramide

**Label:** Metoclopramide

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prucalopride

**Description:** Prokinetic

**Name:** Prucalopride

**Other Names:**

- Resolor

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Metoclopramide

**Description:** Prokinetic

**Name:** Metoclopramide

**Other Names:**

- Primperan

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Gastric residual volume

**Time Frame:** 7 days

#### Secondary Outcomes

**Description:** Enteral nutrition volume ratio

**Measure:** Determining the adequacy of enteral nutrition:

**Time Frame:** 7 days

**Description:** C reactive protein

**Measure:** Incidence of infectious complications.

**Time Frame:** one month

**Description:** duration of stay in intensive care unit

**Measure:** Length of ICU stay

**Time Frame:** 3 months

**Description:** occurence of adverse drug events

**Measure:** Adverse drug events

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Kasr Al Ainy Hospital

**Zip:** 11865

#### Overall Officials

**Official 1:**

**Affiliation:** Future University in Egypt

**Name:** Eman Elmokadem, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000065127

- Term: Dopamine D2 Receptor Antagonists

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000054368

- Term: Laxatives

- ID: D000058828

- Term: Serotonin 5-HT4 Receptor Agonists

- ID: D000017366

- Term: Serotonin Receptor Agonists

- ID: D000018490

- Term: Serotonin Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M11760

- Name: Metoclopramide

- Relevance: HIGH

- As Found: At 10

- ID: M275353

- Name: Prucalopride

- Relevance: HIGH

- As Found: Polymerase chain reaction

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27664

- Name: Laxatives

- Relevance: LOW

- As Found: Unknown

- ID: M5651

- Name: Cathartics

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M19648

- Name: Serotonin Receptor Agonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008787

- Term: Metoclopramide

- ID: C000406662

- Term: Prucalopride

### Misc Info Module

- Version Holder: 2024-05-24
