Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT03698292
Status:
UNKNOWN
Last Update Posted:
2018-10-05
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C102254', 'term': 'itopride'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric Residual Volume', 'timeFrame': '7 days', 'description': 'Gastric residual volume as a surrogate to gastric emptying by means of gastric ultrasound.\n\nof the study, at midpoint of the study and at the end of the study by guided ultrasonography.'}], 'secondaryOutcomes': [{'measure': 'Determining the adequacy of enteral nutrition', 'timeFrame': '24 hours', 'description': 'By calculating the ratio between administered and prescribed feeds over 24 hours duration (Percentage of feed goal tolerated)'}, {'measure': 'Length of ICU stay', 'timeFrame': '3 months', 'description': 'Length of patients stay in the ICU will be assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically-ill Patients']}, 'referencesModule': {'references': [{'pmid': '28077899', 'type': 'BACKGROUND', 'citation': 'Gholipour Baradari A, Alipour A, Firouzian A, Moarab L, Emami Zeydi A. A Double-Blind Randomized Clinical Trial Comparing the Effect of Neostigmine and Metoclopramide on Gastric Residual Volume of Mechanically Ventilated ICU Patients. Acta Inform Med. 2016 Dec;24(6):385-389. doi: 10.5455/aim.2016.24.385-389.'}, {'pmid': '28079236', 'type': 'BACKGROUND', 'citation': 'Gomes PC, Caporossi C, Aguilar-Nascimento JE, Silva AM, Araujo VM. Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers. Arq Gastroenterol. 2017 Jan-Mar;54(1):33-36. doi: 10.1590/S0004-2803.2017v54n1-06.'}, {'pmid': '33740892', 'type': 'DERIVED', 'citation': 'Elmokadem EM, El Borolossy RM, Bassiouny AM, Hanna MG, Darweesh EAG, Sabri NA. The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study. BMC Gastroenterol. 2021 Mar 19;21(1):126. doi: 10.1186/s12876-021-01712-w.'}]}, 'descriptionModule': {'briefSummary': 'The current study will compare the effectiveness as well as the safety of Itopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aging between 18 and 60 years (of both sexes) who are admitted to the ICU and are expected to stay in the ICU for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mNUTRIC) score is of more than or equal 5.\n\nExclusion Criteria:\n\n* Patients who met the following criteria were excluded:\n\n * Age less than 18 years or more than 60 years.\n * Previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.\n * Clinically significant hepatic dysfunction. (\\>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)\n * Regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.\n * Patients with arrhythmia or atrioventricular blocks.\n * Any condition or comorbid disease that might interfere with gastric emptying such as diabetes.\n * Patients with head injuries.'}, 'identificationModule': {'nctId': 'NCT03698292', 'briefTitle': 'Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Study of The Efficacy and Safety of Itopride For Feeding Intolerance in Critically-ill Patients Receiving Enteral Nutrition', 'orgStudyIdInfo': {'id': '67'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'First group', 'description': 'Metoclopramide 10 mg tablets will be taken by the patients of this group three times daily for 7 days', 'interventionNames': ['Drug: Metoclopramide 10mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second Group', 'description': 'Itopride 50 mg tablets will be taken by the patients of this group three times daily for 7 days', 'interventionNames': ['Drug: Itopride']}], 'interventions': [{'name': 'Itopride', 'type': 'DRUG', 'description': 'Prokinetic Drug', 'armGroupLabels': ['Second Group']}, {'name': 'Metoclopramide 10mg', 'type': 'DRUG', 'description': 'Prokinetic Drug', 'armGroupLabels': ['First group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maha Hanna, MD', 'role': 'CONTACT', 'email': 'mahagamil@hotmail.com', 'phone': '01227342966'}], 'facility': 'Kasr Al Ainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Eman Elmokadem, MSc.', 'role': 'CONTACT', 'email': 'emy_101_@hotmail.com', 'phone': '01006242110'}, {'name': 'Maha Gameel, MD', 'role': 'CONTACT', 'email': 'mahagamil@hotmail.com', 'phone': '01227342966'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Eman Mohamed El Mokadem', 'investigatorAffiliation': 'Future University in Egypt'}}}}