Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03478618
Status:
UNKNOWN
Last Update Posted:
2018-03-27
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hypotension', 'timeFrame': '1 hour', 'description': 'decrease in systolic blood pressure more than 20% of base line'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension Drug-Induced']}, 'referencesModule': {'references': [{'pmid': '18333521', 'type': 'BACKGROUND', 'citation': 'Ansari MR, Laghari MS, Solangi KB. Acute renal failure in pregnancy: one year observational study at Liaquat University Hospital, Hyderabad. J Pak Med Assoc. 2008 Feb;58(2):61-4.'}, {'pmid': '21240869', 'type': 'BACKGROUND', 'citation': 'Ganesan C, Maynard SE. Acute kidney injury in pregnancy: the thrombotic microangiopathies. J Nephrol. 2011 Sep-Oct;24(5):554-63. doi: 10.5301/JN.2011.6250.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 36 weeks gestation\n* singleton pregnant women planned for elective caesarian section\n\nExclusion Criteria:\n\n* patient refusal.\n* psychiatric disorders.\n* parturient \\<36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.\n* absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).'}, 'identificationModule': {'nctId': 'NCT03478618', 'briefTitle': 'Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome', 'orgStudyIdInfo': {'id': 'haemodynamics in preeclampsia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group R', 'description': '30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative.', 'interventionNames': ['Drug: Lactated Ringer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group L', 'description': '30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative.', 'interventionNames': ['Drug: Lactated Ringer']}], 'interventions': [{'name': 'Lactated Ringer', 'type': 'DRUG', 'description': 'Patients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia.\n\nGroup (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups', 'armGroupLabels': ['Group L', 'Group R']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zein El Abadin Zarae Hassan, PhD', 'role': 'CONTACT', 'email': 'zein20002002@yahoo.com', 'phone': '01005187371'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Bola Fawzi Mekhail Sedrak', 'investigatorAffiliation': 'Assiut University'}}}}