Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT03428451
Status:
UNKNOWN
Last Update Posted:
2018-12-26
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylaxis Versus Treatment for TURP Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-23', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-02-04', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum sodium level measured in mEq/L', 'timeFrame': '72 hours', 'description': 'Hyponatremia was defined as a serum sodium \\< 130 mEq/L'}], 'secondaryOutcomes': [{'measure': 'Incidence of TURP syndrome', 'timeFrame': '72 hours', 'description': 'Occurring TURP syndrome manifestations'}, {'measure': 'Need for ICU admission', 'timeFrame': '72 hours', 'description': 'For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TURP', 'hypertonic saline', 'TURP syndrome', 'hyponatraemia'], 'conditions': ['Transurethral Resection of Prostate Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the usage \\& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications', 'detailedDescription': 'The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs \\[mean BP, HR, CVP \\& oxygen saturation (spO2)\\] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Adult male BPH patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA class I - III BPH patients\n\nExclusion Criteria:\n\n* Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.\n* Electrolyte imbalance,\n* Uncontrolled hypertension,\n* Congestive heart failure or being allergic to local anesthetics.'}, 'identificationModule': {'nctId': 'NCT03428451', 'briefTitle': 'Prophylaxis Versus Treatment for TURP Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline', 'orgStudyIdInfo': {'id': 'N02112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Hypertonic saline )', 'description': 'patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.', 'interventionNames': ['Drug: NaCl 3% HS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Hypertonic saline)', 'description': 'patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.', 'interventionNames': ['Drug: NaCl 3% HS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C (Normal saline)', 'description': 'patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.', 'interventionNames': ['Drug: NaCl 0.9% NS']}], 'interventions': [{'name': 'NaCl 3% HS', 'type': 'DRUG', 'otherNames': ['Hypertonic saline'], 'description': 'Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.', 'armGroupLabels': ['Group A (Hypertonic saline )']}, {'name': 'NaCl 3% HS', 'type': 'DRUG', 'otherNames': ['Hypertonic saline'], 'description': 'Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.', 'armGroupLabels': ['Group B (Hypertonic saline)']}, {'name': 'NaCl 0.9% NS', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.', 'armGroupLabels': ['Group C (Normal saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed ELbadawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine- Cairo University- Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Mohamed ELbadawy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University', 'investigatorFullName': 'Ahmed Mohamed ELbadawy', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}