Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT00628160
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2008-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terlipressin in Septic Shock in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2008-02-22', 'studyFirstSubmitQcDate': '2008-03-03', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital survival', 'timeFrame': 'Hospitalization'}], 'secondaryOutcomes': [{'measure': 'Refractory shock', 'timeFrame': 'ICU admission'}, {'measure': 'Variceal bleeding', 'timeFrame': 'ICU admission'}, {'measure': 'Hepatorenal syndrome', 'timeFrame': 'Hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Septic shock', 'Cirrhosis', 'Survival'], 'conditions': ['Liver Cirrhosis', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal bleeding are the main causes of death of these patients. Terlipressin administration could prevent these complications and improve survival in this setting.\n\nAim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic patients with severe sepsis or septic shock.\n\nMethods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with severe sepsis or septic shock who will be randomized to receive terlipressin plus alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo). Changes in vasoactive systems and cytokines levels will be also evaluated.', 'detailedDescription': 'Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis. Impact of terlipressin administration on shock reversal, changes in vasoactive systems, inflammatory response, incidence of variceal bleeding and type-1 HRS and ICU and hospital mortality was investigated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 80 years;\n2. Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;\n3. Diagnosis of septic shock based on the presence of data compatible with systemic inflammatory response syndrome, a mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation, and need for circulatory support with vasopressor drugs.\n\nExclusion Criteria:\n\n1. More than 24 hours of evolution of the shock;\n2. Cardiac index \\< 2,5 l/min;\n3. History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;\n4. Pregnancy;\n5. Advanced hepatocellular carcinoma (Milan criteria);\n6. Previous history of transplantation;\n7. Uncontrolled gastrointestinal bleeding.'}, 'identificationModule': {'nctId': 'NCT00628160', 'briefTitle': 'Terlipressin in Septic Shock in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial', 'orgStudyIdInfo': {'id': '05-SS-JFDEZ-1'}, 'secondaryIdInfos': [{'id': 'EUDRACAT-2005-000439-56'}, {'id': '2005-000439-56', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Terlipressin group', 'description': 'Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)', 'interventionNames': ['Drug: Terlipressin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)', 'interventionNames': ['Drug: alpha adrenergic drugs']}], 'interventions': [{'name': 'Terlipressin', 'type': 'DRUG', 'otherNames': ['Glypressin'], 'description': 'Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.', 'armGroupLabels': ['Terlipressin group']}, {'name': 'alpha adrenergic drugs', 'type': 'DRUG', 'otherNames': ['Dopamine and/or norepinephrine'], 'description': 'Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Javier Fernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}, {'name': 'Vicente Arroyo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We are currently writing the manuscript'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Hepatologist Consultant', 'investigatorFullName': 'Vicente Arroyo Perez', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}