Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT05108792
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2021-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Deep Sedation Until Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of end-of-life sedative practices', 'timeFrame': 'after patient death (before january 1st 2020)', 'description': "Information concerning end-of-life sedative practices are recorder in the CRF (treatments used, patient's and unit characteristics...)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Limit or Stop Treatment in Intensive Care', 'Continuous deep sedation (CDS)', 'Continuous deep sedation until death (CDSUD)'], 'conditions': ['Terminal Care']}, 'descriptionModule': {'briefSummary': 'This research is a descriptive observational study conducted in multicenter (intensive care and continuing care units) in France. All data collected is part of the patient record. The main objective is to describe the end-of-life sedative practices following a decision to limit or stop therapy in intensive care unit and continuing care unit.', 'detailedDescription': 'All participating sites will include last 10 consecutive major patients deceased following a decision to limit or stop therapeutics. The study include only data from patients died before January 1, 2020. In the case report form the following information will be entered:\n\n* the characteristics of the unit of intensive care or continuing care unit.\n* Patient Characteristics\n* Characteristics of sedative practices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients at the time of death (\\>18years) Died in intensive care or in continuing care unit following a decision to limit or stop therapeutics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients at the time of death (\\>18years)\n* Died in intensive care or in continuing care unit\n* Patient died before January 1st, 2020.\n* Patients deceased following a decision to limit or stop therapeutics\n\nExclusion Criteria:\n\n* Patients who died of brain death or unexpected cardiac arrest at death of unsuccessful cardiopulmonary resuscitation\n* Patient who expressed during his lifetime his opposition to the use of his data for scientific research'}, 'identificationModule': {'nctId': 'NCT05108792', 'acronym': 'SPCMD-REA', 'briefTitle': 'Continuous Deep Sedation Until Death', 'organization': {'class': 'OTHER', 'fullName': "Société Française d'Anesthésie et de Réanimation"}, 'officialTitle': 'Continuous Deep Sedation Until Death Following a Decision to Limit or Stop Treatment in Intensive Care and in Continuous Surveillance Units', 'orgStudyIdInfo': {'id': 'SPCMD-REA / NR 2020-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients deceased following a decision to limit or stop therapeutics', 'description': 'a', 'interventionNames': ['Other: NO INTERVENTION']}], 'interventions': [{'name': 'NO INTERVENTION', 'type': 'OTHER', 'description': 'observational study, no intervention performed', 'armGroupLabels': ['Patients deceased following a decision to limit or stop therapeutics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Arras', 'country': 'France', 'facility': 'CH Arras', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'city': 'Ars-Laquenexy', 'country': 'France', 'facility': 'CHR Metz Thionville', 'geoPoint': {'lat': 49.09377, 'lon': 6.26989}}, {'city': 'Aurillac', 'country': 'France', 'facility': "CH Henri Mondor d'Aurillac", 'geoPoint': {'lat': 44.92539, 'lon': 2.43983}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Château-Thierry', 'country': 'France', 'facility': 'Centre Hospitalier de Chateau Thierry', 'geoPoint': {'lat': 49.04636, 'lon': 3.40304}}, {'city': 'Clamart', 'country': 'France', 'facility': "Hôpital d'Instruction des Armées Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand - Site de Gabriel Montpied - Neuroréanimation', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand - Site de Gabriel Montpied - Réa médico chir', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon - Réa hépato digestive', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon - Réa neuro chir', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Dax', 'country': 'France', 'facility': 'CH de DAX', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble - Hôpital A Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Jossigny', 'country': 'France', 'facility': 'Hôpital privé de Marne la Vallée', 'geoPoint': {'lat': 48.83765, 'lon': 2.75432}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'Groupe Hospitalier LITTORAL ATLANTIQUE', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Laon', 'country': 'France', 'facility': 'Centre Hospitalier de Laon - Réanimation Polyvalente', 'geoPoint': {'lat': 49.5631, 'lon': 3.62714}}, {'city': 'Le Chesnay', 'country': 'France', 'facility': 'CH de Versailles - André Mignot', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille - Réa Neurochirurgicale', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille - service de déchocage et de soins intensifs - Urgence', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille- Hôpital Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU la Timone 2 - Pôle GEST - RUSH', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Nord Aphm', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'CH Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'city': 'Montélimar', 'country': 'France', 'facility': 'Centre Hospitalier de Montélimar', 'geoPoint': {'lat': 44.55468, 'lon': 4.75469}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hopital Gui de Chauliac - Réa médicale', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hopital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU MONTPELLIER - Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier - Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Mulhouse', 'country': 'France', 'facility': 'Groupe hospitalier de la région de Mulhouse et Sud-Alsace _ GHRMSA Mulhouse', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHRU de NANCY', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes, Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Pasteur 2 - CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Privé Gériatrique Les Sources- Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Nouméa', 'country': 'France', 'facility': 'Centre Hospitalier territorial de Nouméa en Nouvelle Calédonie'}, {'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'country': 'France', 'facility': 'Centre Hospitalier Sainte-Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHU Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmologique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière - Réa neuro chir', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière - Réanimation Polyvalente', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière Paris - SSPI', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'hôpital Saint Antoine - Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes - Réanimation chirurgicale', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes - Réanimation CTCV', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Romans', 'country': 'France', 'facility': 'Hôpitaux Drôme Nord - Site de Romans', 'geoPoint': {'lat': 46.1198, 'lon': 5.02486}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen - Réanimation cardiaque chirurgicale', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Grégoire', 'country': 'France', 'facility': 'Centre Hospitalier Privé Saint-Grégoire', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHRU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulon', 'country': 'France', 'facility': "Hôpital d'Instruction des Armées Sainte Anne", 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse - Hôpital Pierre-Paul', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse-Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil - Toulouse - Réanimation de Néphrologie et Transplantation', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours, Site Trousseau - Réa chir', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours, Site Trousseau - URTC-B', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Vannes', 'country': 'France', 'facility': 'Centre Hospitalier Bretagne Atlantique de Vannes', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Matthieu LE DORZE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GH Lariboisière-St Louis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Société Française d'Anesthésie et de Réanimation", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}