Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 10:49 AM
Study NCT ID:
NCT00793559
Status:
UNKNOWN
Last Update Posted:
2008-11-19
First Post:
2008-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terlipressin Administration in Septic Shock Refractory to Catecholamines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077585', 'term': 'Terlipressin'}], 'ancestors': [{'id': 'D008236', 'term': 'Lypressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-11-18', 'studyFirstSubmitDate': '2008-11-18', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CI, SVR,HR,BP, noradrenalin administration,renal function', 'timeFrame': '6 mo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['septic shock refractory to catecholamines'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* septic shock patients receiving above 0.5 mcg/kg NA\n\nExclusion Criteria:\n\n* allergy to terlipressin, CHF, IHD, pregnancy'}, 'identificationModule': {'nctId': 'NCT00793559', 'briefTitle': 'Terlipressin Administration in Septic Shock Refractory to Catecholamines', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II', 'orgStudyIdInfo': {'id': '161/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'terlipressin bolus', 'description': '1 mg of terlipressin received one time only', 'interventionNames': ['Drug: terlipressin']}, {'type': 'EXPERIMENTAL', 'label': 'terlipressin drip', 'interventionNames': ['Drug: terlipressin']}], 'interventions': [{'name': 'terlipressin', 'type': 'DRUG', 'otherNames': ['glypressin'], 'description': '1 mg of terlipressin one time only', 'armGroupLabels': ['terlipressin bolus']}, {'name': 'terlipressin', 'type': 'DRUG', 'description': '1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h', 'armGroupLabels': ['terlipressin drip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Zrifin', 'country': 'Israel', 'facility': 'Asaf Harofeh MC'}], 'centralContacts': [{'name': 'Tal Mann, Dr', 'role': 'CONTACT', 'email': 'tal_mb@hotmail.com', 'phone': '97257345789'}], 'overallOfficials': [{'name': 'Tal Mann, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asaf Harofeh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr Yuval Leonov', 'oldOrganization': 'Assaf-Harofeh Medical Center'}}}}