Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-10 @ 4:19 AM
Study NCT ID:
NCT02040350
Status:
COMPLETED
Last Update Posted:
2014-01-20
First Post:
2014-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028797', 'term': 'pralidoxime'}, {'id': 'D010091', 'term': 'Oximes'}], 'ancestors': [{'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'duration of ICU stay', 'timeFrame': 'upto one year'}], 'primaryOutcomes': [{'measure': 'mortality rate', 'timeFrame': 'upto one year'}], 'secondaryOutcomes': [{'measure': 'duration of ventilation', 'timeFrame': 'upto one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pralidoxime, atropine, organophosphorous poisoning.'], 'conditions': ['Deaths']}, 'referencesModule': {'references': [{'pmid': '17706760', 'type': 'BACKGROUND', 'citation': 'Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. doi: 10.1016/S0140-6736(07)61202-1.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)', 'detailedDescription': 'The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhistory of alleged organophosphorus intake age \\> 14 years \\< 60 years clinical signs and symptoms of organophosphorus poisoning.\n\nExclusion Criteria:\n\n\\< 14 years or \\> 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses\n\n≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.'}, 'identificationModule': {'nctId': 'NCT02040350', 'briefTitle': 'Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?', 'organization': {'class': 'OTHER', 'fullName': 'Sheri Kashmir Institute of Medical Sciences'}, 'officialTitle': 'Study Effect of WHO Recommended Dose of Pralidoxime in the Treatment of Organophosphorus Poisoning', 'orgStudyIdInfo': {'id': 'U1111-1151-9883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was given to compare the effects', 'interventionNames': ['Drug: Pralidoxime']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pralidoxime', 'description': 'Pralidoxime for treating organophosphorous poisoning patients', 'interventionNames': ['Drug: Pralidoxime']}], 'interventions': [{'name': 'Pralidoxime', 'type': 'DRUG', 'otherNames': ['Oximes'], 'description': 'Pralidoxime was compared to placebo to study the effects of the drug on mortatlity', 'armGroupLabels': ['Placebo', 'Pralidoxime']}]}, 'contactsLocationsModule': {'locations': [{'zip': '190006', 'city': 'Srinagar', 'state': 'Srinagar Kashmir', 'country': 'India', 'facility': 'Sheri kashmir insititute of medical sciences', 'geoPoint': {'lat': 34.08565, 'lon': 74.80555}}], 'overallOfficials': [{'name': 'Showkat Gurcoo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SKIMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheri Kashmir Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registar', 'investigatorFullName': 'Tariq Wani', 'investigatorAffiliation': 'Sheri Kashmir Institute of Medical Sciences'}}}}