Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT05032261
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICU Norepinephrine Load
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D007362', 'term': 'Intensive Care Units'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Day 5', 'description': 'Mortality within 5 days of the date of ICU admission for circulatory shock according to norepinephrine intensity'}], 'secondaryOutcomes': [{'measure': 'Intensity', 'timeFrame': 'Day 5', 'description': 'Intensity mortality relationship according to norepinephrine duration'}, {'measure': 'Time/Dose Ratio', 'timeFrame': 'Day 5', 'description': 'ratio between time of use and cumulative dose'}, {'measure': 'Norepinephrine dose', 'timeFrame': 'Day 5', 'description': 'score of increasing norepinephrine dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Norepinephrine load dose', 'vasopressor dose intensity', 'vasopressor exposure'], 'conditions': ['Circulatory Collapse and Shock']}, 'referencesModule': {'references': [{'pmid': '39193888', 'type': 'RESULT', 'citation': 'Ceausu D, Boulet N, Roger C, Alonso S, Lefrant JY, Boisson C, Mura T, Muller L. CRITICAL NOREPINEPHRINE DOSE TO PREDICT EARLY MORTALITY DURING CIRCULATORY SHOCK IN INTENSIVE CARE: A RETROSPECTIVE STUDY IN 3423 ICU PATIENTS OVER 4-YEAR PERIOD. Shock. 2024 Nov 1;62(5):682-687. doi: 10.1097/SHK.0000000000002454. Epub 2024 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Norepinephrine is recommended as first-line vasopressor in critically ill patients, regardless of shock etiology. Its advantages over dopamine and/or epinephrine have been demonstrated, especially by reducing tachycardia events. The current guidelines recommend a mean arterial pressure of at least 65 mmHg that in the resuscitation from sepsis-induced hypoperfusion. Some study reported that delay in initiation of vasopressor therapy was associated with an increase mortality risk in patient with septic shock .The recent experts\' opinion suggest that " vasopressors should be started early, before (complete) completion of fluid ressuscitation ".\n\nIn the event of refractory septic shock, high-dose vasopressors may be used. The precise maximal dose of norepinephrine associated with mortality excess has been poorly studied. High doses have been defined by a cutoff value ranging from 0.5 μg/kg/min to 2 μg/kg/min and recently by 1 μg/kg/min for mortality at 90% and by 0,75 μg/kg/min for mortality at 60%. Furthermore, an increasing vasopressor dosing intensity during the first 24 hours after shock septic was associated with increased mortality depending of fluid administration. If a threshold value of norepinephrine score can be obtained, it could indicate the association with another vasopressor such as vasopressin or surrogates.\n\nThe primary aim of the present study aimed to confirm if a given norepinephrine dose is associated with mortality. The secondary aims were the link between mortality and norepinephrine duration, cumulative dose in order to build a score that predicts a futility of increasing norepinephrine dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with circulatory shock admitted in intensive care unit (ICU) and receiving norepinephrine. All patients older than 18 years recorded between January 1, 2015 and December 31, 2019 were included. Patients with circulatory shock without norepinephrine were excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* circulatory shock and admitted in ICU\n* with norepinephrine\n\nExclusion Criteria : Patient without norepinephrine or missing data.'}, 'identificationModule': {'nctId': 'NCT05032261', 'acronym': 'ICU_NE_LOAD', 'briefTitle': 'ICU Norepinephrine Load', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Norepinephrine Load and Relationship With Prognosis in Critically Patients With Circulatory Shock', 'orgStudyIdInfo': {'id': 'LOCAL/2021/DC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: surviving Patients', 'description': 'Patients surviving within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine', 'interventionNames': ['Drug: Circulatory shock with norepinephrine in ICU']}, {'label': 'Group 2: Deceased patients', 'description': 'Patients deceased within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine', 'interventionNames': ['Drug: Circulatory shock with norepinephrine in ICU']}], 'interventions': [{'name': 'Circulatory shock with norepinephrine in ICU', 'type': 'DRUG', 'description': 'Circulatory shock with norepinephrine in ICU', 'armGroupLabels': ['Group 1: surviving Patients', 'Group 2: Deceased patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Laurent Muller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}