Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-31 @ 8:48 PM
Study NCT ID:
NCT04272632
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coload Optimization Guided by Inferior Vena Cava Collapsibility Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)', 'timeFrame': 'Baseline (before preload)', 'description': 'IVC-CI = \\[(IVC-max-IVC-min) /IVC-max\\*100%\\]'}, {'measure': 'The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)', 'timeFrame': 'Before spinal anesthesia (after preload)', 'description': 'IVC-CI = \\[(IVC-max-IVC-min) /IVC-max\\*100%\\]'}, {'measure': 'The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)', 'timeFrame': '5 min after spinal anesthesia', 'description': 'IVC-CI = \\[(IVC-max-IVC-min) /IVC-max\\*100%\\]'}, {'measure': 'The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)', 'timeFrame': '5 min after fetal delivery', 'description': 'IVC-CI = \\[(IVC-max-IVC-min) /IVC-max\\*100%\\]'}, {'measure': 'The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)', 'timeFrame': 'Before leaving the operating room', 'description': 'IVC-CI = \\[(IVC-max-IVC-min) /IVC-max\\*100%\\]'}], 'secondaryOutcomes': [{'measure': 'The incidence of post-spinal anesthesia hypotension.', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 80% of the baseline.'}, {'measure': 'The incidence of severe post-spinal anesthesia hypotension.', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 60% of the baseline'}, {'measure': 'The incidence of nausea and vomiting.', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Presence of nausea and vomiting in patients after spinal anesthesia'}, {'measure': 'The incidence of bradycardia', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Heart rate \\< 55 beats/min.'}, {'measure': 'The incidence of hypertension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\>120% of the baseline'}, {'measure': 'pH', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical vein blood gases'}, {'measure': 'Partial pressure of oxygen', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical vein blood gases'}, {'measure': 'Base excess', 'timeFrame': 'Immediately after delivery', 'description': 'From umbilical vein blood gases'}, {'measure': 'APGAR score', 'timeFrame': '1min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}, {'measure': 'APGAR score', 'timeFrame': '5min after delivery', 'description': 'A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration'}, {'measure': 'Overall stability of systolic blood pressure control versus baseline', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Evaluated by performance error (PE).'}, {'measure': 'Overall stability of heart rate control versus baseline', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Evaluated by performance error (PE).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coload', 'Inferior vena cava collapsibility index', 'Norepinephrine', 'Cesarean section', 'Dose-finding'], 'conditions': ['Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the optimal coload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.', 'detailedDescription': "Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, our study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of coload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal coload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years\n* Primipara or multipara\n* Singleton pregnancy ≥37 weeks\n* American Society of Anesthesiologists physical status classification I to II\n* Scheduled for elective cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Body height \\< 150 cm\n* Body weight \\> 100 kg or body mass index (BMI) ≥ 40 kg/m2\n* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg\n* Hemoglobin \\< 7g/dl\n* Fetal distress, or known fetal developmental anomaly'}, 'identificationModule': {'nctId': 'NCT04272632', 'briefTitle': 'Coload Optimization Guided by Inferior Vena Cava Collapsibility Index', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Coload Optimization Guided by Inferior Vena Cava Collapsibility Index in Parturients With Prophylactic Norepinephrine Infusion Undergoing Cesarean Section: a Randomized, Dose-finding Trial', 'orgStudyIdInfo': {'id': 'Yi Chen-2020-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 ml/kg group', 'description': '4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.', 'interventionNames': ['Drug: 4 ml/kg group']}, {'type': 'EXPERIMENTAL', 'label': '8 ml/kg group', 'description': '8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.', 'interventionNames': ['Drug: 8 ml/kg group']}, {'type': 'EXPERIMENTAL', 'label': '12 ml/kg group', 'description': '12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.', 'interventionNames': ['Drug: 12 ml/kg group']}], 'interventions': [{'name': '4 ml/kg group', 'type': 'DRUG', 'otherNames': ['Crystalloid'], 'description': '4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.', 'armGroupLabels': ['4 ml/kg group']}, {'name': '8 ml/kg group', 'type': 'DRUG', 'otherNames': ['Crystalloid'], 'description': '8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.', 'armGroupLabels': ['8 ml/kg group']}, {'name': '12 ml/kg group', 'type': 'DRUG', 'otherNames': ['Crystalloid'], 'description': '12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.', 'armGroupLabels': ['12 ml/kg group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}], 'overallOfficials': [{'name': 'Xinli Ni, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}