Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-04-23 @ 3:14 AM
Study NCT ID:
NCT02780466
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Intubation in Septic Shock
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 859}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': '28 days after ICU admission'}], 'secondaryOutcomes': [{'measure': 'duration of organ support', 'timeFrame': '28 days', 'description': 'mechanical ventilation, vasopressors, renal replacement therapy'}, {'measure': 'impact of intubation delay on outcome', 'timeFrame': '28 days'}]}, 'conditionsModule': {'keywords': ['Septic shock', 'Endotracheal intubation', 'Outcome'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '35672860', 'type': 'DERIVED', 'citation': 'Mellado-Artigas R, Ferrando C, Martino F, Delbove A, Ferreyro BL, Darreau C, Jacquier S, Brochard L, Lerolle N. Early intubation and patient-centered outcomes in septic shock: a secondary analysis of a prospective multicenter study. Crit Care. 2022 Jun 7;26(1):163. doi: 10.1186/s13054-022-04029-6.'}, {'pmid': '32449053', 'type': 'DERIVED', 'citation': 'Darreau C, Martino F, Saint-Martin M, Jacquier S, Hamel JF, Nay MA, Terzi N, Ledoux G, Roche-Campo F, Camous L, Pene F, Balzer T, Bagate F, Lorber J, Bouju P, Marois C, Robert R, Gaudry S, Commereuc M, Debarre M, Chudeau N, Labroca P, Merouani K, Egreteau PY, Peigne V, Bornstain C, Lebas E, Benezit F, Vally S, Lasocki S, Robert A, Delbove A, Lerolle N. Use, timing and factors associated with tracheal intubation in septic shock: a prospective multicentric observational study. Ann Intensive Care. 2020 May 24;10(1):62. doi: 10.1186/s13613-020-00668-6.'}]}, 'descriptionModule': {'briefSummary': 'Septic shock is common in intensive care and its mortality remains high. While new treatments have not improved survival, optimization of known and widely used techniques has allowed reduction in mortality. Thus improving care given to patients starts with making better use of existing resuscitation techniques. Among these practices, mechanical ventilation is widespread in the management of patients with septic shock. In large studies published in recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical ventilation. It therefore appears that a significant proportion of patients are never intubated during treatment and management of their septic shock. There is no specific recommendation from critical care societies concerning mechanical ventilation in the treatment of septic shock. Apart from indisputable situations such as impaired consciousness or acute respiratoire distress, the decision whether to ventilate mechanically or not is left to the discretion of the physician.\n\nThe aim of this study is to analyze intubation practice in septic shock patients and its impact on 28-day survival.\n\nThis multicentric and observational study will be conducted in 30 French ICUs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the study are adults patients admitted to intensive care unit in France (about 30 centers) for shock, supposed or confirmed of septic origin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old\n* Admitted in the ICU for septic shock\n* Introduction of vasopressors ( norepinephrine or adrenaline ) in the ICU or within 24 hours of ICU admission\n* Suspected or proven infection\n\nExclusion Criteria:\n\n* Intubation before the introduction of vasopressors\n* Decision of withdrawing or withholding care at admission\n* Pregnant woman\n* Patient not affiliated to the social security insurance\n* Refusal of participation in the study'}, 'identificationModule': {'nctId': 'NCT02780466', 'acronym': 'INTUBATIC', 'briefTitle': 'Observational Study on Intubation in Septic Shock', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'orgStudyIdInfo': {'id': '2015-96'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with septic shock'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator for medical research', 'investigatorFullName': 'DENISE JOLIVOT', 'investigatorAffiliation': 'University Hospital, Angers'}}}}