Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-23 @ 8:48 PM
Study NCT ID:
NCT04110418
Status:
UNKNOWN
Last Update Posted:
2019-10-01
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure', 'timeFrame': '24hours', 'description': 'The time taken to reach adequate mean blood pressure\n\nReduction in the dosage of the standard inotropic support'}], 'secondaryOutcomes': [{'measure': 'to assess the effect of intervention on survival', 'timeFrame': '4 days', 'description': 'mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methylene blue', 'terlipressin', 'septic shock', 'preterm neonate'], 'conditions': ['Neonatal Sepsis', 'Refractory Shock']}, 'descriptionModule': {'briefSummary': 'A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate', 'detailedDescription': 'The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Neonate with Gestational age at birth ≤ 36weeks\n\nInclusion Criteria:\n\n* diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell\n* Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \\>0.5 mcg/kg/min)\n* consent form\n\nExclusion Criteria:\n\n* known case of G6pd deficiency\n* Hx of drug allergy MB, NE, terlipressin\n* Patients with severely impaired renal function.\n* History of maternal drug intake of selective serotonin reuptake inhibitors,and Serotonin-Norepinephrine Reuptake Inhibitors'}, 'identificationModule': {'nctId': 'NCT04110418', 'briefTitle': 'Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate', 'orgStudyIdInfo': {'id': 'FWA000017586'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylene Blue group (Group MB)', 'description': 'Methylene Blue is supplied in 1 ml or 10 mL single-dose ampules. Each 1 mL ampule contains 10 mg of methylene blue as a clear dark blue solution\n\n* Any unused product or waste material should be disposed of in accordance with local practice,\n* For administration to be diluted before use in a solution of 50 mL 5% Dextrose in Water (D5W) in order to avoid local pain, particularly in the paediatric population. Use the diluted solution immediately after preparation.\n* Do not mix with sodium chloride 9 mg/mL (0.9%) solution for injection, because it has been demonstrated that chloride reduces the solubility of methylene blue.', 'interventionNames': ['Drug: Methylene Blue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Terlipressin Group (Group TP )', 'description': 'The active substance is terlipressin acetate. Each ampoule contains\n\n1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml.\n\n* The powder is to be dissolved in the enclosed solvent and slowly administered intravenously. Further dilution up to 10 ml with sterile isotonic sodium chloride solution is possible.\n* Store in a refrigerator at 2-8˚C.\n* Keep the ampoules in the outer carton in order to protect from light', 'interventionNames': ['Drug: Methylene Blue']}], 'interventions': [{'name': 'Methylene Blue', 'type': 'DRUG', 'otherNames': ['terlipressin acetate'], 'description': 'Methylene Blue group (Group MB):will receive IV MB initiated with a first loading dose ( 1 mg/kg over 30 minutes ) then continuous IV infusion( 0.15 mg/kg per hour for up to 24 hours)\n\nTerlipressin Group (Group TP) Terlipressin will be initiated with a loading dose ( 2 μg/kg intravenous over 30 minutes ) followed by continuous IV infusion starting by 2 μg/kg/h escalating up every 15 minutes up to 20 μg/kg/h', 'armGroupLabels': ['Methylene Blue group (Group MB)', 'Terlipressin Group (Group TP )']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Cairo', 'state': 'Abbasia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'rabab allam, physician', 'role': 'CONTACT', 'email': 'dr_rabab_asu@hotmail.com', 'phone': '01119069425', 'phoneExt': '202'}], 'facility': 'Neonatal Intensive Care Units (NICUs), Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'rabab allam, physician', 'role': 'CONTACT', 'email': 'dr_rabab_asu@hotmail.com', 'phone': '01119069425', 'phoneExt': '202'}], 'overallOfficials': [{'name': 'rabab allam, physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ain shams university faculty of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Rabab Gameel Abd EL hamid allam', 'investigatorAffiliation': 'Ain Shams University'}}}}