Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT04702906
Status:
UNKNOWN
Last Update Posted:
2021-01-11
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '7 days', 'description': 'mortality rate'}], 'secondaryOutcomes': [{'measure': 'Duration of ventilation', 'timeFrame': '7 days', 'description': 'Duration of mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aluminum Phosphide Poisoning']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the potential adjuvant therapeutic effect of trimetazidine in treatment of acute AlP poisoning-induced cardiotoxicity.', 'detailedDescription': 'Aluminium phosphide (AlP) is an inorganic phosphide. It is used as a fumigant to protect stored grains from insects, rodents and other pests.It is a solid fumigant widely used in Egypt as a grain preservative. Its tablets are commonly used due to their low cost, high efficacy, and availability .\n\nToxic effects of AlP are related to phosphine gas release when AlP comes in contact with moisture or gastric acidity. Phosphine gas is rapidly absorbed from the gastrointestinal tract and lungs inhibiting cytochrome-c oxidase and oxidative phosphorylation which results in adenosine triphosphate depletion and resulting cellualr death.\n\nThe direct toxic effects of phosphine on cardiac myocytes, fluid loss and adrenal gland can induce profound circulatory collapse. Phosphides and phosphine can exert a direct corrosive effect on body tissues.\n\nToxic manifestations usually appear rapidly upon phosphide exposure. Impaired myocardial contractility, fluid loss, pulmonary edema, metabolic acidosis and acute renal failure are the most frequent manifestations. Disseminated intravascular coagulation and hepatic necrosis may also occur. Patients generally die due to multi-organ failure .However, myocardial damage- induced cardiovascular collapse is reported to be the primary cause of death.\n\nSeverity of manifestations depends on different factors such as dose, exposure route, and time delay before treatment initiation. Diagnosis is based on history of exposure, garlic odor of the breath, suggestive clinical manifestations and detection of phosphine gas in gastric aspirate or breath.\n\nTreatment of acute AlP toxicity is mainly supportive as there is no specific antidote since the exact mechanism of toxicity is still unknown. The most important factor is resuscitation of shock. Many researches are directed towards finding a specific treatment for this fatal poison.\n\nTrimetadizine is described as the first cytoprotective anti-ischemic agent developed. It has a protective of the myocardium due to its preservation of oxidative metabolism. It improves myocardial glucose utilization through inhibition of long-chain 3-ketoacyl CoA thiolase activity, which results in a reduction in fatty acid oxidation and a stimulation of glucose oxidation .\n\nTrimetadizine reduces the tissue accumulation of malonyldialdehyde, the lipid peroxidation index, and the sodium influx related to activation of the Na+ -K + pump. Moreover, it lack of haemodynamic effects. These effects result in a decrease in the cellular accumulation of calcium and improved intracellular ATP levels).\n\nOral administration of the anti-ischaemic drug trimetazidine, was tried in a case report of occupational inhalation exposure to phosphine gas from AlP. It was temporally associated with clinical improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included in this study will be diagnosed as acute aluminum phosphide poisoning by history and clinical pictures.\n\n * Age is18 years or older.\n\nExclusion Criteria:\n\n* Pregnant and lactating women.\n* Patients with ingestion or exposure to other substances in addition to aluminum phosphide.\n* Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).'}, 'identificationModule': {'nctId': 'NCT04702906', 'briefTitle': 'Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Aluminum Phosphide Poisoning'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'All patients will continue to receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation, and antiarrhythmic agents if indicated.', 'interventionNames': ['Other: standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'trimetazidine group', 'description': 'The trimetazidine group will receive conventional standard treatment plus Trimetazidine dihydrochloride "metacardia" ® (20 mg three times daily produced by Pharco-Egypt) will be administered twice every 24 hours until at least treatment is no longer needed.', 'interventionNames': ['Other: standard treatment', 'Drug: trimetazidine hydrochloride "metacardia" ® 20 mg tablet']}], 'interventions': [{'name': 'standard treatment', 'type': 'OTHER', 'description': 'Standard treatment if indicated.', 'armGroupLabels': ['control group', 'trimetazidine group']}, {'name': 'trimetazidine hydrochloride "metacardia" ® 20 mg tablet', 'type': 'DRUG', 'description': 'trimetazidine hydrochloride "metacardia" ® (20 mg three times daily produced by Global NAPI Pharmaceuticals-Egypt)', 'armGroupLabels': ['trimetazidine group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'nadia helal, MD', 'role': 'CONTACT', 'email': 'dr_nadia_helal86@yahoo.com', 'phone': '00201099752866'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Nadia Helal', 'investigatorAffiliation': 'Tanta University'}}}}