Continuous Deep Sedation Until Death (SPCMD-REA)
November 4, 2021 updated by: Société Française d'Anesthésie et de Réanimation
Continuous Deep Sedation Until Death Following a Decision to Limit or Stop Treatment in Intensive Care and in Continuous Surveillance Units
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.
Study Overview
Detailed Description
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:
- the characteristics of the unit of intensive care or continuing care unit.
- Patient Characteristics
- Characteristics of sedative practices
Study Type
Observational
Enrollment (Actual)
585
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amiens, France
- CHU Amiens
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Angers, France
- CHU Angers
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Arras, France
- CH Arras
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Ars-Laquenexy, France
- CHR Metz Thionville
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Aurillac, France
- CH Henri Mondor d'Aurillac
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Besançon, France
- CHU Jean Minjoz
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Château-Thierry, France
- Centre Hospitalier de Chateau Thierry
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Clamart, France
- Hôpital d'Instruction des Armées Percy
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Clermont-Ferrand, France
- CHU Clermont-Ferrand - Site de Gabriel Montpied - Neuroréanimation
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Clermont-Ferrand, France
- CHU Clermont-Ferrand - Site de Gabriel Montpied - Réa médico chir
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Clichy, France
- Hôpital Beaujon - Réa hépato digestive
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Clichy, France
- Hôpital Beaujon - Réa neuro chir
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Dax, France
- CH de Dax
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Grenoble, France
- CHU de Grenoble - Hôpital A Michallon
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Jossigny, France
- Hôpital privé de Marne la Vallée
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La Rochelle, France
- Groupe Hospitalier Littoral Atlantique
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Laon, France
- Centre Hospitalier de Laon - Réanimation Polyvalente
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Le Chesnay, France
- CH de Versailles - André Mignot
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Le Kremlin-Bicêtre, France
- Hôpital Bicêtre
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Lille, France
- CHRU de Lille - Réa Neurochirurgicale
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Lille, France
- CHRU de Lille - service de déchocage et de soins intensifs - Urgence
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Lille, France
- CHRU de Lille- Hôpital Huriez
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Marseille, France
- Hopital Nord APHM
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Marseille, France
- CHU la Timone 2 - Pôle GEST - RUSH
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Mont-de-Marsan, France
- CH Mont de Marsan
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Montpellier, France
- CHU Montpellier - Hôpital Lapeyronie
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Montpellier, France
- CHU de Montpellier - Hôpital Gui de Chauliac
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Montpellier, France
- CHU Montpellier - Hôpital Arnaud de Villeneuve
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Montpellier, France
- CHU de Montpellier - Hopital Gui de Chauliac - Réa médicale
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Montélimar, France
- Centre Hospitalier de Montelimar
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Mulhouse, France
- Groupe hospitalier de la région de Mulhouse et Sud-Alsace _ GHRMSA Mulhouse
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Nancy, France
- CHRU de Nancy
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Nantes, France
- CHU Nantes, Hôtel-Dieu
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Nice, France
- Hôpital Pasteur 2 - CHU de Nice
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Nice, France
- Hôpital Privé Gériatrique Les Sources- Nice
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Nouméa, France
- Centre Hospitalier territorial de Nouméa en Nouvelle Calédonie
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Nîmes, France
- CHU de Nimes
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Orléans, France
- Centre Hospitalier d'Orléans
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Paris, France
- Hôpital Lariboisière
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Paris, France
- Fondation Ophtalmologique Adolphe de Rothschild
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Paris, France
- Centre Hospitalier Sainte-Anne
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Paris, France
- Chu Bichat Claude Bernard
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Paris, France
- Hôpital Pitié-Salpêtrière - Réa neuro chir
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Paris, France
- Hôpital Pitié-Salpêtrière - Réanimation Polyvalente
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Paris, France
- Hôpital Pitié-Salpêtrière Paris - SSPI
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Paris, France
- Hopital Saint Antoine - Paris
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Poitiers, France
- CHU de Poitiers
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Reims, France
- CHU de Reims
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Rennes, France
- CHU de Rennes - Réanimation chirurgicale
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Rennes, France
- CHU de Rennes - Réanimation CTCV
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Romans, France
- Hôpitaux Drôme Nord - Site de Romans
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Rouen, France
- CHU de Rouen
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Rouen, France
- CHU Rouen - Réanimation cardiaque chirurgicale
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Saint-Grégoire, France
- Centre Hospitalier Prive Saint-Gregoire
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Strasbourg, France
- CHRU Strasbourg
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Toulon, France
- Hôpital d'Instruction des Armées Sainte Anne
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Toulouse, France
- Clinique Pasteur
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Toulouse, France
- CHU de Toulouse - Hôpital Pierre-Paul
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Toulouse, France
- CHU de Toulouse-Rangueil
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Toulouse, France
- CHU Rangueil - Toulouse - Réanimation de Néphrologie et Transplantation
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Tours, France
- CHRU Tours, Site Trousseau - Réa chir
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Tours, France
- CHRU Tours, Site Trousseau - URTC-B
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Vannes, France
- Centre Hospitalier Bretagne Atlantique de Vannes
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Villejuif, France
- Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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
Description
Inclusion Criteria:
- Adult patients at the time of death (>18years)
- Died in intensive care or in continuing care unit
- Patient died before January 1st, 2020.
- Patients deceased following a decision to limit or stop therapeutics
Exclusion Criteria:
- Patients who died of brain death or unexpected cardiac arrest at death of unsuccessful cardiopulmonary resuscitation
- Patient who expressed during his lifetime his opposition to the use of his data for scientific research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients deceased following a decision to limit or stop therapeutics
a
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observational study, no intervention performed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of end-of-life sedative practices
Time Frame: after patient death (before january 1st 2020)
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Information concerning end-of-life sedative practices are recorder in the CRF (treatments used, patient's and unit characteristics...)
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after patient death (before january 1st 2020)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Matthieu LE DORZE, MD, GH Lariboisière-St Louis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2021
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
October 14, 2021
First Submitted That Met QC Criteria
November 4, 2021
First Posted (Actual)
November 5, 2021
Study Record Updates
Last Update Posted (Actual)
November 5, 2021
Last Update Submitted That Met QC Criteria
November 4, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPCMD-REA / NR 2020-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.