Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT03716895
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2018-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Septic Shock Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-21', 'studyFirstSubmitDate': '2018-10-13', 'studyFirstSubmitQcDate': '2018-10-21', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactate clearance', 'timeFrame': '30 days', 'description': 'Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L'}], 'secondaryOutcomes': [{'measure': 'Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy', 'timeFrame': '28 days', 'description': 'Number of days from the last day free of vasopressors, mechanical ventilation and Renal Replacement Therapy up to day 28. If patients dies it scores 0.'}, {'measure': 'Mechanical Ventilation-free days', 'timeFrame': '28 days', 'description': 'Days free of mechanical ventilation up to day 28'}, {'measure': 'Vasopressors-free days', 'timeFrame': '28 days', 'description': 'Days free of vasopressors up to day 28'}, {'measure': 'Rate of Acute Kidney Injury', 'timeFrame': '28 days', 'description': 'Kidney Disease: Improving Global Outcomes definition'}, {'measure': 'ICU length of stay', 'timeFrame': '28 days', 'description': 'Days in ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': '30 days', 'description': 'Days in Hospital'}, {'measure': 'Rate of In-hospital Mortality', 'timeFrame': '30 days', 'description': 'Any cause mortality'}, {'measure': 'Rate of Acute Respiratory Distress Syndrome', 'timeFrame': '28 days', 'description': 'Berlin definition'}, {'measure': 'Rate of New Atrial Fibrilation', 'timeFrame': '28 days', 'description': 'New atrial fibrilation requiring treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Septic Shock', 'Lactate clearance', 'Acute Kidney Injury', 'Days alive and free', 'Ventilation-free days', 'Vasopressor-free days'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '26020231', 'type': 'BACKGROUND', 'citation': "Venot M, Weis L, Clec'h C, Darmon M, Allaouchiche B, Goldgran-Toledano D, Garrouste-Orgeas M, Adrie C, Timsit JF, Azoulay E. Acute Kidney Injury in Severe Sepsis and Septic Shock in Patients with and without Diabetes Mellitus: A Multicenter Study. PLoS One. 2015 May 28;10(5):e0127411. doi: 10.1371/journal.pone.0127411. eCollection 2015."}, {'pmid': '30304656', 'type': 'BACKGROUND', 'citation': 'Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.'}, {'pmid': '29490185', 'type': 'BACKGROUND', 'citation': 'Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.'}, {'pmid': '29801010', 'type': 'BACKGROUND', 'citation': 'McIntyre WF, Um KJ, Alhazzani W, Lengyel AP, Hajjar L, Gordon AC, Lamontagne F, Healey JS, Whitlock RP, Belley-Cote EP. Association of Vasopressin Plus Catecholamine Vasopressors vs Catecholamines Alone With Atrial Fibrillation in Patients With Distributive Shock: A Systematic Review and Meta-analysis. JAMA. 2018 May 8;319(18):1889-1900. doi: 10.1001/jama.2018.4528.'}]}, 'descriptionModule': {'briefSummary': 'Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019.\n\nThe primary goal is to look for risk factors associated with an increased in lactate clearance\n\nSecondary goals are the following:\n\n1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay.\n2. To look for risk factors associated with an increase risk of Acute Kidney Injury.\n3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.\n4. To look for risk factors associated with a decrease in Ventilator-free days.\n5. To look for risk factors associated with a decrease in Vasopressor-free days.\n6. To look for risk factors associated with an increase risk of in-hospital mortality.\n7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.\n8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.\n9. To compare and validate different risk scores in our cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults older than 18 years old admitted to ICU with Severe Septic Shock\n\nExclusion Criteria:\n\n* Rejecting participation by not signing informed consent form.'}, 'identificationModule': {'nctId': 'NCT03716895', 'briefTitle': 'Severe Septic Shock Complications', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}, 'officialTitle': 'Identifying Risk Factors for Complications in Severe Septic Shock', 'orgStudyIdInfo': {'id': 'SSS-500'}}, 'contactsLocationsModule': {'locations': [{'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'contacts': [{'name': 'Marc Vives, PhD, DESA', 'role': 'CONTACT', 'email': 'marcvives50@gmail.com', 'phone': '+34972940200'}, {'name': 'Judit Lopez, MD', 'role': 'CONTACT', 'email': 'judit.lofe@gmail.com', 'phone': '+34972940200'}], 'facility': 'Hospital Universitari Dr Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}], 'centralContacts': [{'name': 'Marc Vives, PhD, DESA', 'role': 'CONTACT', 'email': 'marcvives50@gmail.com', 'phone': '+34972940200'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Lead. Department of Anesthesiology & Critical Care', 'investigatorFullName': 'Marc Vives', 'investigatorAffiliation': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta"}}}}