Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04509258
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D000108', 'term': 'Acetylcarnitine'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-09', 'studyFirstSubmitDate': '2020-08-09', 'studyFirstSubmitQcDate': '2020-08-09', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality rate reduction', 'timeFrame': '1 year', 'description': 'the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets'}, {'measure': 'organ damage reduction', 'timeFrame': '1 year', 'description': 'another primary end point is to reduce organ damage and injury for survivors'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N-acetyl cysteine', 'Acety L- carnitine', 'paraffin oil', 'aluminium phosphide'], 'conditions': ['the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage']}, 'descriptionModule': {'briefSummary': 'Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study\n\nExclusion Criteria:\n\n1. Patients less than 18\n2. Patients presented with delay time exceeding 12 hours after acute intoxication.\n3. Patients with history of cardiac, renal or hepatic diseases.\n4. Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.'}, 'identificationModule': {'nctId': 'NCT04509258', 'briefTitle': 'Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial', 'orgStudyIdInfo': {'id': 'R 66/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines', 'interventionNames': ['Drug: Sodium Bicarbonate Powder and ondansetron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N- acetyl cysteine grouo', 'description': 'N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines', 'interventionNames': ['Drug: N-acetyl cysteine', 'Drug: Sodium Bicarbonate Powder and ondansetron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetyl L-carnitine group', 'description': 'Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided', 'interventionNames': ['Dietary Supplement: acetyl L-carnitine', 'Drug: Sodium Bicarbonate Powder and ondansetron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medicated paraffin oil group', 'description': 'Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines', 'interventionNames': ['Drug: medicated paraffin oil', 'Drug: Sodium Bicarbonate Powder and ondansetron']}], 'interventions': [{'name': 'N-acetyl cysteine', 'type': 'DRUG', 'description': 'a drug which can have an off label use as an antidot for aluminium phosphide poisoning in addition to sodium bicarbonate and ondansetron as standard of care', 'armGroupLabels': ['N- acetyl cysteine grouo']}, {'name': 'acetyl L-carnitine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Naturallu occuring amino acid derivative which can be taken as a dietary supplement involves in mitochondrial function and energy production and is suggested to have a role in lowering organ damage resulting from aluminium phosphide poisonong in addition to sodium bicarbonate and ondansetron as standard of care', 'armGroupLabels': ['Acetyl L-carnitine group']}, {'name': 'medicated paraffin oil', 'type': 'DRUG', 'description': 'refined mixture of liquid hydrocarbons which used as laxative and is suggested to reduce absorption of aluminium phosphide if taken within two hours of administration of the toxin in addition to sodium bicarbonate and ondansetron as standard of care', 'armGroupLabels': ['Medicated paraffin oil group']}, {'name': 'Sodium Bicarbonate Powder and ondansetron', 'type': 'DRUG', 'description': 'standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide', 'armGroupLabels': ['Acetyl L-carnitine group', 'Medicated paraffin oil group', 'N- acetyl cysteine grouo', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'state': 'Abbasya', 'country': 'Egypt', 'contacts': [{'name': 'Walaa Abdel Hamid, PhD', 'role': 'CONTACT', 'email': 'walaa.abdelhamid@gmail.com', 'phone': '+201062261010'}, {'name': 'Dalia Zaafar, PhD', 'role': 'CONTACT', 'email': 'dr.moda88@gmail.com', 'phone': '+201117922833'}], 'facility': 'Poison Control Center of Ain-Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mahmoud Sakr, PhD', 'role': 'CONTACT', 'email': 'mahmoud.sakr@hotmail.com', 'phone': '+201117922833'}, {'name': "Hanan Abdel Wahab, Master's", 'role': 'CONTACT', 'email': 'hanan.abdelwahab@yahoo.com', 'phone': '+201062261010'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual paticipant data is decided not to be shared for the privacy of the patients as patients in each group will be coded in numbers instead of their names'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pharmacology', 'investigatorFullName': 'Dalia K. Zaafar', 'investigatorAffiliation': 'Cairo University'}}}}