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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05641051
Other study ID # 35298/2/22
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 14, 2022
Est. completion date June 16, 2023

Study information

Verified date June 2023
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 16, 2023
Est. primary completion date June 16, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: 1. Patients' age 20 - 60 years. 2. Either gender. 3. Mechanically ventilated head trauma patients. 4. Patients receiving enteral feeding via nasogastric tube. Exclusion Criteria: 1. Patients with contraindications to enteral feeding. 2. Patients with extrapyramidal manifestations. 3. Patients with known allergy to metoclopramide. 4. Patients with seizures. 5. Patients with renal or hepatic diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metoclopramide
Cases will receive 10 mg intravenous metoclopramide every 6 hours.
Placebo
Cases will receive the same volume of IV placebo / 6 hours.

Locations

Country Name City State
Egypt Tanta University Hospitals Tanta ElGharbiaa

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the risk of aspiration 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.
8 hours interval during first 5 days of enteral feeding
Secondary Incidence of ventilator associated pneumonia 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)
8 hours interval during first 5 days of enteral feeding
Secondary Time of weaning from mechanical ventilation Time of weaning from mechanical ventilation From the start of enteral feeding From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
Secondary Hospital stay Hospital stay including intensive care and ward. From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
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