Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05641051
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2022-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The drugs will be prepared by a dedicated anesthesiologist who is aware of the allocated group and will have no subsequent role in the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-17', 'studyFirstSubmitDate': '2022-11-27', 'studyFirstSubmitQcDate': '2022-12-04', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the risk of aspiration', 'timeFrame': '8 hours interval during first 5 days of enteral feeding', 'description': 'Aspiration risk will be categorized using the system proposed by Ven de Putte and Perlas. As:\n\n* patients with empty antrum and gastric residual volume \\< 1.5 mL/kg: low risk.\n* patients with solid contents or gastric residual volume \\> 1.5 mL/kg: high risk.'}], 'secondaryOutcomes': [{'measure': 'Incidence of ventilator associated pneumonia', 'timeFrame': '8 hours interval during first 5 days of enteral feeding', 'description': '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.\n\nInfectious Diseases. Society of America (IDSA) and the American Thoracic. Society (ATS)'}, {'measure': 'Time of weaning from mechanical ventilation', 'timeFrame': 'From the start of enteral feeding till intensive care discharge through study completion, an average of 6months', 'description': 'Time of weaning from mechanical ventilation From the start of enteral feeding'}, {'measure': 'Hospital stay', 'timeFrame': 'From the start of enteral feeding till intensive care discharge through study completion, an average of 6months', 'description': 'Hospital stay including intensive care and ward.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Emptying', 'Mechanically Ventilation', 'Randomized Controlled Trial', 'Metoclopramide']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients' age 20 - 60 years.\n2. Either gender.\n3. Mechanically ventilated head trauma patients.\n4. Patients receiving enteral feeding via nasogastric tube.\n\nExclusion Criteria:\n\n1. Patients with contraindications to enteral feeding.\n2. Patients with extrapyramidal manifestations.\n3. Patients with known allergy to metoclopramide.\n4. Patients with seizures.\n5. Patients with renal or hepatic diseases."}, 'identificationModule': {'nctId': 'NCT05641051', 'briefTitle': 'Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effects of Metoclopramide Administration on Gastric Emptying in Mechanically Ventilated Critically Ill Patients : A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '35298/2/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metoclopramide group', 'description': 'Patients will receive 10 mg intravenous metoclopramide / 6 hours.', 'interventionNames': ['Drug: Metoclopramide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive the same volume of intravenous placebo / 6 hours.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metoclopramide', 'type': 'DRUG', 'description': 'Cases will receive 10 mg intravenous metoclopramide every 6 hours.', 'armGroupLabels': ['Metoclopramide group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Cases will receive the same volume of IV placebo / 6 hours.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'ElGharbiaa', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Data will be available upon reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesia, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Khadija Mohammed Elbaradei', 'investigatorAffiliation': 'Tanta University'}}}}