Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT00440102
Status:
COMPLETED
Last Update Posted:
2011-09-22
First Post:
2007-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D005045', 'term': 'Etomidate'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-21', 'studyFirstSubmitDate': '2007-02-23', 'studyFirstSubmitQcDate': '2007-02-23', 'lastUpdatePostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA)', 'timeFrame': 'at the end of D2'}], 'secondaryOutcomes': [{'measure': 'Mortality, length of stay in the intensive care unit and in the hospital, length of stay under artificial ventilation, neurological state at the exit of the hospital and adverse effects : within the first 28 days.', 'timeFrame': 'at D0'}, {'measure': 'intubation difficulty', 'timeFrame': 'at D0'}, {'measure': 'early complications', 'timeFrame': 'at D0'}, {'measure': 'adverse effects', 'timeFrame': 'at D0'}, {'measure': 'SOFA in the first 48 hours of hospitalization', 'timeFrame': 'at the ende of D2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ETOMIDATE', 'KETAMINE', 'RAPID SEQUENCE INTUBATION', 'PREHOSPITAL', 'During rapid sequence intubation'], 'conditions': ['Intubation; Difficult']}, 'referencesModule': {'references': [{'pmid': '19573904', 'type': 'RESULT', 'citation': 'Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.'}, {'pmid': '19573905', 'type': 'RESULT', 'citation': 'Wenzel V, Lindner KH. Best pharmacological practice in prehospital intubation. Lancet. 2009 Jul 25;374(9686):267-8. doi: 10.1016/S0140-6736(09)61071-0. Epub 2009 Jul 1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.', 'detailedDescription': 'The national recommendations of sedation concerning the intubation in emergency settings advise the use of a hypnotic, etomidate associated to succinylcholine. A national inquiry showed that more than 80% of prehospital intubations use a rapid sequence intubation as sedation. However, several recent studies throw into question the use of etomidate in this indication. Indeed, etomidate is a powerful inhibitor of the synthesis of cortisol. Adrenocortical hormone insufficiency is clearly associated to an increase in the morbidity-mortality of critically ill patients. Several authors advise therefore against the use of etomidate for such patients. Yet, to date, only indirect arguments associating the use of etomidate with excessive morbidity-mortality exist. A real causality link is not yet established. Another hypnotic that could constitute a therapeutic alternative to the use of etomidate exists: ketamine. The advantage of this molecule is that it does not inhibit the adrenocortical hormone axis.\n\nObjectives: To evaluate sedation using ketamine versus etomidate in term of morbidity-mortality in critically ill patients intubated in the prehospital setting.\n\nExperimental diagram: A prospective, multicentric, randomized, controlled, simple blind trial with independent analysis of the primary outcome.\n\nThe expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation. The risks incurred for patients being suitable to this research are bound essentially to the adverse effects of ketamine. These include some psycho-dyslectic manifestations: nightmare, unpleasant awakening, and disruption of the visual, auditory sensations and mood, a sensation to float and sometimes depersonalization. These adverse effects are warned by a continuous administration of benzodiazepines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requiring sedation for prehospital endotracheal intubation\n* Age ≥ 18 years\n* Consent of a family member if present, then of the patient for the pursuit of research\n\nExclusion Criteria:\n\n* Patient in cardiac arrest\n* Presence of contraindication to succinylcholine:\n\n * Personal or familial history of malignant hyperthermia\n * Known hypersensitivity to succinylcholine\n * Skeletal muscle disease\n * Myasthenia\n * Known hyperkalemia\n * Severe ophthalmic injury\n * Known congenital deficit in plasmatic pseudo-cholinesterase\n* Presence of contraindication to ketamine:\n\n * Known hypersensitivity to ketamine\n * Known porphyria\n * Severe hypertension\n* Presence of contraindication to etomidate:\n\n * Known untreated adrenal insufficiency\n * Known hypersensitivity to etomidate\n* Known pregnancy\n* Unaffiliated patient to the social insurance'}, 'identificationModule': {'nctId': 'NCT00440102', 'acronym': 'KETASED', 'briefTitle': 'Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity', 'orgStudyIdInfo': {'id': 'P060213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'ketamine', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Etomidate', 'interventionNames': ['Drug: Etomidate']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine', 'armGroupLabels': ['1']}, {'name': 'Etomidate', 'type': 'DRUG', 'description': 'Etomidate', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Chu Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'overallOfficials': [{'name': 'Frederic ADNET, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}