Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-19 @ 10:38 AM
Study NCT ID:
NCT03924804
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2019-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077331', 'term': "Ringer's Solution"}], 'ancestors': [{'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Doppler Ultrasonography Assessed Bladder and Blood Volume'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-12', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-20', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. The change of bladder volume', 'timeFrame': 'baseline and 10 minutes before leaving the post-anesthesia care unite', 'description': 'bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystolithiasis and Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'The objective of the trial was to explore the effect of different infusion volume on perioperative bladder and blood volume in patients undergoing daytime surgery assisted by bladder and vascular ultrasound and transthoracic echocardiography.', 'detailedDescription': "The objective of the trial was to evaluate the effects of different infusion volume of Ringer's solution acetate (2 ml/kg,8ml/kg, 16ml/kg) on bladder volume, hemodynamics,transthoracic echocardiography and vascular ultrasound including the inferior vena cava(IVC) and the right subclavian vein(SCV) diameter and the IVC and SCV collapsibility index in patients undergoing daytime surgery through a randomized controlled clinical study, so as to provide better guidance for clinical transfusion avoiding bladder catheterization . The patients in this trial were visited before induction and discharge from the postanaesthesia .We also collected the first time and times of micturition and whether the patients have the dysuria."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. ethnic Chinese;\n* 2\\. age, 18 to 65 years old;\n* 3\\. American Society of Anaesthesiologists (ASA) physical status I or II;\n* 4\\. Daytime patients scheduled for general anesthesia\n\nExclusion Criteria:\n\n* Patients unwilling to cooperate with the experiment\n* Body mass index exceeding 30 kg/m2;\n* Patients with a history of heart ,liver and Renal failure ,hypertension,diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.\n* Patients with the urinary diseases, such as kidney, ureteral calculi and tumors, prostatic hypertrophy.'}, 'identificationModule': {'nctId': 'NCT03924804', 'briefTitle': 'Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.', 'orgStudyIdInfo': {'id': '20190418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: 2 ml/kg group', 'interventionNames': ["Drug: Ringer's solution acetate"]}, {'type': 'EXPERIMENTAL', 'label': 'Group B: 8 ml/kg group', 'interventionNames': ["Drug: Ringer's solution acetate"]}, {'type': 'EXPERIMENTAL', 'label': 'Group C: 16 ml/kg group', 'interventionNames': ["Drug: Ringer's solution acetate"]}], 'interventions': [{'name': "Ringer's solution acetate", 'type': 'DRUG', 'description': "Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.", 'armGroupLabels': ['Group A: 2 ml/kg group']}, {'name': "Ringer's solution acetate", 'type': 'DRUG', 'description': "Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.", 'armGroupLabels': ['Group B: 8 ml/kg group']}, {'name': "Ringer's solution acetate", 'type': 'DRUG', 'description': "Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.", 'armGroupLabels': ['Group C: 16 ml/kg group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wen-fei Tan', 'investigatorAffiliation': 'China Medical University, China'}}}}