A Phase 4 interventional study of Metoclopramide and Placebo in Gastric Emptying, Mechanically Ventilation and Randomized Controlled Trial, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Tanta University · Phase 4, Interventional, and Prevention
The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .
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
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive 10 mg intravenous metoclopramide / 6 hours.
Drug: Metoclopramide
Patients will receive the same volume of intravenous placebo / 6 hours.
Drug: Placebo
Cases will receive 10 mg intravenous metoclopramide every 6 hours.
Cases will receive the same volume of IV placebo / 6 hours.
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.
Time frame: 8 hours interval during first 5 days of enteral feeding
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)
Time frame: 8 hours interval during first 5 days of enteral feeding
Time of weaning from mechanical ventilation
Time of weaning from mechanical ventilation From the start of enteral feeding
Time frame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
Hospital stay
Hospital stay including intensive care and ward.
Time frame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
Plan to share: Yes — Data will be available upon reasonable request from the corresponding author
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Tanta University