Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01493102
Status:
TERMINATED
Last Update Posted:
2015-01-30
First Post:
2011-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Discontinuation Order of Vasopressors in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D009638', 'term': 'Norepinephrine'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'whyStopped': 'Futility by interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-28', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hypotension', 'timeFrame': 'One hour after dose reduction of vasopressors', 'description': 'Hypotension is defined as mean arterial pressure is less than 65mmHg'}], 'secondaryOutcomes': [{'measure': 'Time of hypotension', 'timeFrame': 'One hour after dose reduction of vasopressors', 'description': 'Time interval (min) from time of dose reduction of vasopressors to time to development of hypotension'}, {'measure': 'Vasopressor free day', 'timeFrame': '28 days after dose reduction of vasopressors'}, {'measure': '28-day mortality', 'timeFrame': '28 days', 'description': 'All cause mortality within 28 days after hospitalization'}, {'measure': 'ICU mortality', 'timeFrame': '3 months', 'description': 'All cause mortlity during ICU admission'}, {'measure': 'In-hospital mortality', 'timeFrame': '3 months', 'description': 'All cause mortality during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['septic shock', 'norepinephrine', 'vasopressin', 'hypotension'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '29784057', 'type': 'DERIVED', 'citation': 'Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.', 'detailedDescription': 'There are little data regarding the discontinuation of vasopressors in patients with septic shock. Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients 20 years of age or older\n* patients of receiving concomitant therapy with norepinephrine and vasopressin for teh management of septic shock\n* patients began to reduce the vasopressor\n\nExclusion Criteria:\n\n* patients who expired or had care withdrawn while receiving norepinephrine and vasopressin\n* patients being transferred into the ICU from an outside facility or the operating room\n* patients who are suspected to have vasopressin deficiency (eg. HPA axis dysfunction, empty sella)\n* acute myocardial infarction or Congestive heart failure (NYHA functional classification III or IV)\n* acute mesenteric ischemia\n* patients who were received other vasopressor except for norepinephrine or vasopressin'}, 'identificationModule': {'nctId': 'NCT01493102', 'acronym': 'DOVSS', 'briefTitle': 'Discontinuation Order of Vasopressors in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock', 'orgStudyIdInfo': {'id': '2011-09-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vasopressin', 'description': 'Vasopressin will be reduced first (0.01 U/hour)', 'interventionNames': ['Drug: Vasopressin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norepinephrine', 'description': 'Norepinephrine: Norepinephrine will be reduced first (0.1 microgram/kg/hour)', 'interventionNames': ['Drug: Norepinephrine']}], 'interventions': [{'name': 'Vasopressin', 'type': 'DRUG', 'description': 'Vasopressin will be reduced first (0.01 U/hour)', 'armGroupLabels': ['Vasopressin']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'description': 'Norepinephrine will be reduced first (0.1 microgram/kg/hour)', 'armGroupLabels': ['Norepinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'kyeongman Jeon, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Kyeongman Jeon', 'investigatorAffiliation': 'Samsung Medical Center'}}}}