Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT05997303
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2023-07-17', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on stroke volume index \\[ml/m\\^2\\] using invasive uncalibrated pulse wave analysis (MostcareUP System).'}, {'measure': 'Explorative aim - effect on (advanced) hemodynamic variables - heart rate', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on heart rate \\[beats/minute\\] using invasive uncalibrated pulse wave analysis (MostcareUP System).'}, {'measure': 'Explorative aim - effect on (advanced) hemodynamic variables - cardiac index', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on cardiac index \\[l/min/m\\^2\\] using invasive uncalibrated pulse wave analysis (MostcareUP System).'}, {'measure': 'Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on systemic vascular resistance index \\[dyn × s × cm\\^-5 × m\\^2\\] using invasive uncalibrated pulse wave analysis (MostcareUP System).'}, {'measure': 'Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on pulse pressure variation \\[%\\] using invasive uncalibrated pulse wave analysis (MostcareUP System).'}], 'primaryOutcomes': [{'measure': 'Blood pressure stability', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'Generalized average real variability (gARV) of mean arterial pressure (MAP) within the first 15 minutes of anesthetic induction \\[mmHg/min\\]; the gARV is the sum of absolute values of the differences between neighboring measurements for all measurements divided by the total measurement duration in \\[mmHg/min\\].'}], 'secondaryOutcomes': [{'measure': 'Area under MAP', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'Area under a MAP of 65, 60, 50, and 40 mmHg \\[mmHg × min\\]. MAP will be measured using intraarterial blood pressure monitoring.'}, {'measure': 'Cumulative duration of a MAP below', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'Cumulative duration of a MAP \\<65, \\<60, \\<50, and \\<40 mmHg \\[min\\]. MAP will be measured using intraarterial blood pressure monitoring.'}, {'measure': 'Area above MAP', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'Area above a MAP of 100, 110, 120, and 140 mmHg \\[mmHg × min\\]. MAP will be measured using intraarterial blood pressure monitoring.'}, {'measure': 'Cumulative duration of a MAP above', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'Cumulative duration of a MAP \\>100, \\>110, \\>120, and \\>140 mmHg \\[min\\]. MAP will be measured using intraarterial blood pressure monitoring.'}, {'measure': 'Cumulative dose of norepinephrine', 'timeFrame': 'Measurement period of 15 minutes starting at the beginning of the anesthetic induction', 'description': 'Cumulative dose of norepinephrine indexed to body weight \\[μg/kg\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure stability'], 'conditions': ['Blood Pressure', 'Perioperative Hypotension']}, 'referencesModule': {'references': [{'pmid': '40744797', 'type': 'DERIVED', 'citation': 'Vokuhl C, Kouz K, Flick M, Krause L, Kroker A, Moll-Khosrawi P, Zollner C, Sessler DI, Saugel B, Thomsen KK. Continuous versus bolus norepinephrine administration and arterial blood pressure stability during induction of general anaesthesia in high-risk noncardiac surgery patients: a randomised trial. Br J Anaesth. 2025 Oct;135(4):878-885. doi: 10.1016/j.bja.2025.06.025. Epub 2025 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized trial investigating whether continuous norepinephrine administration via an infusion pump - compared to manual bolus administration - increases blood pressure stability within the first 15 minutes of anesthetic induction in non-cardiac surgery patients.\n\nThe secondary endpoints area under a MAP of 65, 60, 50, and 40 mmHg \\[mmHg × min\\], cumulative duration of a MAP \\<65, \\<60, \\<50, and \\<40 mmHg \\[min\\], area above a MAP of 100, 110, 120, and 140 mmHg \\[mmHg min\\], cumulative duration of a MAP \\>100, \\>110, \\>120, and \\>140 mmHg \\[min\\] and cumulative dose of norepinephrine indexed to body weight \\[μg/kg\\] within the first 15 minutes of anesthetic induction will be assessed.', 'detailedDescription': 'not provided'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 45 years\n* American Society of Anesthesiologists physical status II-IV\n* scheduled for elective major non-cardiac surgery under general anesthesia\n* continuous intraarterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the trial\n* sinus rhythm\n\nExclusion Criteria:\n\n* Clinical indication to use a continuous norepinephrine infusion via an infusion pump during anesthetic induction\n* Need for femoral artery catheterization\n* History of intracranial bleedings or aneurysms\n* Patients who are incapable of giving consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05997303', 'briefTitle': 'Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-101053-BO-ff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Continuous norepinephrine administration', 'description': 'continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists', 'interventionNames': ['Other: Continuous norepinephrine infusion via an infusion pump']}, {'type': 'OTHER', 'label': 'Manual bolus norepinephrine administration', 'description': 'manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists', 'interventionNames': ['Other: Manual bolus norepinephrine administration']}], 'interventions': [{'name': 'Continuous norepinephrine infusion via an infusion pump', 'type': 'OTHER', 'description': 'Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists.', 'armGroupLabels': ['Continuous norepinephrine administration']}, {'name': 'Manual bolus norepinephrine administration', 'type': 'OTHER', 'description': 'Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists.', 'armGroupLabels': ['Manual bolus norepinephrine administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Christina Vokuhl, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}