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Completed

NCT Number: NCT05641051

Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .

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Key information

Conditions

Gastric Emptying Mechanically Ventilation Metoclopramide Randomized Controlled Trial

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

About this study

More than 50% of patients in ICU have gastric dysmotility, which leads to slow gastric emptying(GE) and high gastric residual volume (GRV) and is associated with increased mortality in these patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients' age 20 - 60 years.
  • Either gender.
  • Mechanically ventilated head trauma patients.
  • Patients receiving enteral feeding via nasogastric tube.

Exclusion criteria

  • Patients with contraindications to enteral feeding.
  • Patients with extrapyramidal manifestations.
  • Patients with known allergy to metoclopramide.
  • Patients with seizures.
  • Patients with renal or hepatic diseases.

Treatment and study plan

Metoclopramide

Drug

Cases will receive 10 mg intravenous metoclopramide every 6 hours.

Placebo

Drug

Cases will receive the same volume of IV placebo / 6 hours.

Primary outcomes

  1. Assessment of the risk of aspiration

    Time frame: 8 hours interval during first 5 days of enteral feeding

    Aspiration risk will be categorized using the system proposed by Ven de Putte and Perlas. As:

    • patients with empty antrum and gastric residual volume < 1.5 mL/kg: low risk.
    • patients with solid contents or gastric residual volume > 1.5 mL/kg: high risk.

Secondary outcomes

  1. Incidence of ventilator associated pneumonia

    Time frame: 8 hours interval during first 5 days of enteral feeding

    Pneumonia will be defined according to the ATS/IDSA clinical criteria and will be diagnosed if a new or progressive radiographic infiltrate is present and at least two of the three following clinical features are also present: (1) fever higher than 38°C, (2) leukocytosis or leucopenia and (3) purulent secretions. No microbiological confirmation is required for diagnosis of pneumonia.

    Infectious Diseases. Society of America (IDSA) and the American Thoracic. Society (ATS)

  2. Time of weaning from mechanical ventilation

    Time frame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months

    Time of weaning from mechanical ventilation From the start of enteral feeding

  3. Hospital stay

    Time frame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months

    Hospital stay including intensive care and ward.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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