Gastric EmptyingPhase 4NCT05641051
Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients
A Phase 4 study testing Metoclopramide in people with Gastric Emptying and Mechanically Ventilation, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients . Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gastric Emptying, Mechanically Ventilation, Randomized Controlled Trial
- What is being tested?
- Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2022to 16 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients' age 20 - 60 years.
- Either gender.
- Mechanically ventilated head trauma patients.
- Patients receiving enteral feeding via nasogastric tube.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial
The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .
Read the detailed 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
- Being tested
- Metoclopramide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Cases will receive 10 mg intravenous metoclopramide every 6 hours.
PlaceboDrug
Cases will receive the same volume of IV placebo / 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide group | Experimental | Patients will receive 10 mg intravenous metoclopramide / 6 hours. Receives: Drug: Metoclopramide |
| Control group | Placebo comparator | Patients will receive the same volume of intravenous placebo / 6 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours interval during first 5 days of enteral feeding
Secondary outcomes (3)
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)
Measured: 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
Measured: 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.
Measured: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start14 Dec 2022
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Mohammed Elbaradei, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641051
- Sponsor's protocol ID
- 35298/2/22
- Status last verified
- Jun 2023
- First submitted
- 27 Nov 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05641051
- Acronym / sponsor ID
- 35298/2/22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide group | Experimental | Drug: MetoclopramidePatients will receive 10 mg intravenous metoclopramide / 6 hours. |
| Control group | Placebo comparator | Drug: PlaceboPatients will receive the same volume of intravenous placebo / 6 hours. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients' age 20 - 60 years.
- Either gender.
- Mechanically ventilated head trauma patients.
- Patients receiving enteral feeding via nasogastric tube.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoclopramideCases will receive 10 mg intravenous metoclopramide every 6 hours. | Drug | Metoclopramide group |
| PlaceboCases will receive the same volume of IV placebo / 6 hours. | Drug | Control group |
Primary outcome
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.
3 secondary outcomes
Incidence of ventilator associated pneumonia
Time frame: 8 hours interval during first 5 days of enteral feeding
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
Hospital stay
Time frame: From the start of enteral feeding till intensive care discharge through study completion, an average of 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoclopramide in people with Gastric Emptying and Mechanically Ventilation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the risk of aspiration (time frame: 8 hours interval during first 5 days of enteral feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.