Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT02144766
Status:
UNKNOWN
Last Update Posted:
2014-08-26
First Post:
2014-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-24', 'studyFirstSubmitDate': '2014-05-11', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(before induction of anesthesia), arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 3h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 24h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 48h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 72h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(before induction of anesthesia), arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 3h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 24h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 48h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 72h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(before induction of anesthesia), arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 3h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 24h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 48h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 72h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(before induction of anesthesia), arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 3h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 24h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 48h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 72h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(before induction of anesthesia), arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 3h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 24h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 48h after surgery'}, {'measure': 'change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery', 'timeFrame': 'baseline(before induction of anesthesia), 72h after surgery'}], 'secondaryOutcomes': [{'measure': 'change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(just before the start of surgery), at arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery', 'timeFrame': 'baseline(just before the start of surgery), 3h after surgery'}, {'measure': 'change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(just before the start of surgery), at arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery', 'timeFrame': 'baseline(just before the start of surgery), 3h after surgery'}, {'measure': 'change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit', 'timeFrame': 'baseline(just before the start of surgery), at arrival in the postanesthesia care unit'}, {'measure': 'change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery', 'timeFrame': 'baseline(just before the start of surgery), 3h after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiac Dysfunction', 'Myocardial Injury']}, 'descriptionModule': {'briefSummary': 'The goal of the present study was to investigate the role of pro-inflammatory cytokines in myocardial dysfunction and injury resulting from noncardiac injury in children and whether or not anti-inflammatory treatment with caudal block prevents pro-inflammatory cytokines-associated myocardial dysfunction and injury following noncardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.\n\nExclusion Criteria:\n\n* Children with anemia, electrolyte disturbances, abnormal acid-base status, bleeding diathesis, history of allergy to local anesthetics, neurologic and spinal diseases, skin infections on the caudal area, renal dysfunction, symptomatic cardiovascular and respiratory disease'}, 'identificationModule': {'nctId': 'NCT02144766', 'briefTitle': 'Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block', 'orgStudyIdInfo': {'id': '060717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine', 'description': 'caudal block with 1 ml/kg of ropivacaine 0.2%', 'interventionNames': ['Drug: ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'caudal block with 1 ml/kg of saline', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'ropivacaine', 'type': 'DRUG', 'description': 'caudal block with 1 ml/kg of ropivacaine 0.2%', 'armGroupLabels': ['Ropivacaine']}, {'name': 'saline', 'type': 'DRUG', 'description': 'caudal block with 1 ml/kg of saline', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'SiQin Chen, MD', 'role': 'CONTACT', 'email': 'chensiqin1983@hotmail.com', 'phone': '+8613918085974'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Si-Qin Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'attending doctor', 'investigatorFullName': 'Si-Qin Chen', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}