Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT05927259
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus Pesticide Poisoning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D001285', 'term': 'Atropine'}, {'id': 'D010091', 'term': 'Oximes'}], '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': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Organophosphorus Poisoned Patients']}, 'descriptionModule': {'briefSummary': 'All patients admitted in the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure , clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.\n\nGroup 1 -. Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) and Group 2 - Patients who will receive conventional treatment only', 'detailedDescription': '40 patients with acute organophosphorus poisoning will be randomly assigned as control groups and study group in a 1:1 ratio ( 20 patients in each group). The diagnosis of acute organophosphorus intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.\n\nGroup 1 - Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) Group 2 - Patients who will receive conventional treatment only'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients (above 16 years) admitted to the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. -\n\nExclusion Criteria:\n\n* Based on the possibility of alteration in measured parameters and/or biomarkers, patients below 16 years or above 60 years Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.'}, 'identificationModule': {'nctId': 'NCT05927259', 'briefTitle': 'The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus Pesticide Poisoning', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus.A Randomized, Clinical Trial in Poison Control Center -Ain Shams University Hospitals', 'orgStudyIdInfo': {'id': 'R214/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': 'Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)', 'interventionNames': ['Drug: n acetyl cysteine', 'Drug: standard treatment']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Patients who will receive conventional treatment only', 'interventionNames': ['Drug: standard treatment']}], 'interventions': [{'name': 'n acetyl cysteine', 'type': 'DRUG', 'description': 'A patients received NAC 140 mg/Kg IV infusion (as a loading dose), then 70 mg/KgIV infusion every 4 hours up to 17 doses', 'armGroupLabels': ['study group']}, {'name': 'standard treatment', 'type': 'DRUG', 'otherNames': ['atropine and oximes'], 'description': 'stabilization and antidotes', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'None Selected', 'country': 'Egypt', 'facility': 'faculty of medicine Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11566', 'city': 'Cairo', 'state': 'None Selected', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '02', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Poison Control Center Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sarah S Mohammed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine ain shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of clinical toxicology', 'investigatorFullName': 'Sarah Saeed Mohammed', 'investigatorAffiliation': 'Ain Shams University'}}}}