Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-31 @ 8:37 PM
Study NCT ID:
NCT03715712
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NORepinephrine-Maintaining-individuaALIZEd Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-21', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of postoperative myocardial injury', 'timeFrame': 'baseline and postoperative day 1', 'description': 'the change of hs-cTnT levels'}], 'secondaryOutcomes': [{'measure': 'hospital LOS', 'timeFrame': '1 month', 'description': 'hospital length of stay'}, {'measure': 'ICU LOS', 'timeFrame': '1 month', 'description': 'ICU length of stay'}, {'measure': 'in hospital mortality', 'timeFrame': '1 month', 'description': 'in hospital mortality'}, {'measure': 'Amount of norepinephrine used', 'timeFrame': 'intraoperative', 'description': 'total amount of norepinephrine used'}, {'measure': 'intraoperative vital signs', 'timeFrame': 'intraoperative', 'description': 'blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index'}, {'measure': 'acute myocardial complications', 'timeFrame': '1 month', 'description': 'chest pain, dyspnea, edema, acute coronary syndrome'}, {'measure': 'acute kidney injury', 'timeFrame': 'postoperative 48 hours', 'description': 'serum creatinine increase and urine output'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Myocardial Injury', 'Blood Pressure', 'Non-cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This study compares the effect of individualized vs standard blood pressure management on postoperative myocardial injury in high-risk patients undergoing non-cardiac surgery by measuring the hs-cTnT levels. Continuous norepinephrine infusion is used to target a mean pressure of greater than 65mmHg and a systolic pressure less than 160mmHg in the standardized group while the target is 20% within the ward blood pressure in the individualized group. The pre- and postoperative hs-cTnT levels to detect myocardial injury are compared between the two groups.', 'detailedDescription': "Managing the blood pressure preoperatively is important in high-risk patients because hypotension can lead to perioperative myocardial injury. It has been reported that a systolic pressure of less than 50-55mmHg or greater than 40% decrease can lead to cardiac complications. The mechanism of hypotension leading to postoperative myocardial injury is due to hypoperfusion and ischemic reperfusion injury.\n\nIn this randomized controlled study, the blood pressure for participants in the standardized group is maintained as follows: mean blood pressure greater than 65mmHg and systolic blood pressure less than 160mmHg. The individualized group participants' blood pressure is maintained at a target of 20% within the preoperative ward blood pressure. Anesthesia and intraoperative management are the same in both groups to target a bispectral index level of 50. In order to quantitatively measure the myocardial injury, high sensitive cardiac troponin T (hs-cTnT) will be measured pre- and postoperatively. A level greater than 14ng/dl has been reported to be associated with myocardial injury and mortality. The objective of this study is to show that the standardized protocol of maintaining a mean pressure greater than 65mmHg is non inferior to the individualized management in terms of postoperative myocardial injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for general or urologic surgeries under general anesthesia at Seoul National University Hospital\n* high-risk patients with a revised cardiac risk index of at least 2 points or more\n\nExclusion Criteria:\n\n* severely uncontrolled hypertension (systolic blood pressure ≥ 180mmHg or mean blood pressure ≥ 110)\n* severely uncontrolled hypotension (systolic blood pressure \\< 80mmHg)\n* arrhythmias with symptoms or use of pacemaker\n* transplantation surgery\n* acute or decompensated heart failure\n* acute coronary syndrome\n* sepsis\n* end stage renal disease (GFR \\<30ml/min/1.73m2)\n* contraindications of norepinephrine infusion'}, 'identificationModule': {'nctId': 'NCT03715712', 'briefTitle': 'NORepinephrine-Maintaining-individuaALIZEd Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Individualized vs Standard Blood Pressure Target on the Postoperative Myocardial Injury in High Risk Patients Undergoing Non-cardiac Surgery- a Randomized Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'NORMALIZE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard', 'description': 'Standardized blood pressure management with a target of mean blood pressure greater than 65mmHg and systolic blood pressure lower than 160mmHg', 'interventionNames': ['Other: standardized blood pressure management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individualized', 'description': 'Individualized blood pressure management of 20% within the preoperative ward blood pressure', 'interventionNames': ['Other: Individualized blood pressure management']}], 'interventions': [{'name': 'standardized blood pressure management', 'type': 'OTHER', 'description': 'Standardized blood pressure management of a mean blood pressure \\> 65mmHg and a systolic blood pressure of \\< 160mmHg using norepinephrine continuous infusion', 'armGroupLabels': ['Standard']}, {'name': 'Individualized blood pressure management', 'type': 'OTHER', 'description': 'Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion', 'armGroupLabels': ['Individualized']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chul-Woo Jung, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chul-Woo Jung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}