Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-29 @ 3:17 PM
Study NCT ID:
NCT03038503
Status:
UNKNOWN
Last Update Posted:
2018-08-29
First Post:
2016-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D012769', 'term': 'Shock'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008751', 'term': 'Methylene Blue'}, {'id': 'D000077585', 'term': 'Terlipressin'}], 'ancestors': [{'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2017-01-28', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality rate', 'timeFrame': '7 days'}, {'measure': 'time to wean of vasopressor', 'timeFrame': 'through complete weaning off vasopressor, an average of 24 hours'}, {'measure': 'ICU duration', 'timeFrame': 'through out off indication need ICU care, an average of 7 days'}], 'secondaryOutcomes': [{'measure': 'hemodynamic parameter: Mean arterial pressure (mmHg)', 'timeFrame': 'every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours', 'description': 'mmHg, A-line monitoring'}, {'measure': 'hemodynamic parameter: lactate (mmol/l)', 'timeFrame': 'every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours', 'description': 'mmol/l'}, {'measure': 'hemodynamic parameter: urine output (ml)', 'timeFrame': 'every 2 hr until wean off vasopressor up to 24 hours', 'description': 'ml'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['refractory septic shock', 'catecholamine resistance septic shock', 'terlipressin', 'methylene blue'], 'conditions': ['Septic Shock', 'Refractory Shock']}, 'descriptionModule': {'briefSummary': 'The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue\n\n* Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration\n* Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>15 years old\n* Diagnosis septic shock as SCCM/ACCP\n* Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \\>0.5 mcg/kg/min)\n* Concent form\n\nExclusion Criteria:\n\n* Known case G6PD deficiency\n* Acute respiratory distress syndrome (ARDS)\n* Hx of drug allergy MB, NE, terlipressin\n* Hx of Raynaud's phenomenon, systemic sclerosis, PHT\n* Known case coronary heart disease without treatment\n* Current drug use serotonin reuptake inhibitors (SSRI), Serotonin and norepinephrine reuptake inhibitors (SNRIs)\n* Reject to join project"}, 'identificationModule': {'nctId': 'NCT03038503', 'briefTitle': 'What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin', 'orgStudyIdInfo': {'id': 'ID 09-59-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A', 'description': 'standard care septic shock according sepsis bundles'}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'after defined refractory shock (adequate fluid resuscitation + add NE\\>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr\\*4 hr (intervention add on to standard care)', 'interventionNames': ['Drug: Methylene Blue']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'after defined refractory shock (adequate fluid resuscitation + add NE\\>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)', 'interventionNames': ['Drug: Terlipressin']}], 'interventions': [{'name': 'Methylene Blue', 'type': 'DRUG', 'description': 'after defined refractory shock (need NE\\>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr\\*4 hr (intervention add on to standard care)', 'armGroupLabels': ['B']}, {'name': 'Terlipressin', 'type': 'DRUG', 'description': 'after defined refractory shock (need NE\\>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'munthana sundusadee, md', 'role': 'CONTACT', 'email': 'opal_janeway@hotmail.com', 'phone': '66639010178'}], 'facility': 'Ramathibodi hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'munthana sundusadee, MD', 'role': 'CONTACT', 'email': 'opal_janeway@hotmail.com', 'phone': '66639010178'}], 'overallOfficials': [{'name': 'viratch tangsujaritvijit, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'fellowship in department of pulmonary and critical care department', 'investigatorFullName': 'munthana sundusadee', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}