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

Status

Completed

Conditions

Intervention / Treatment

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

  • France
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • CHU Angers
      • Arras, France
        • CH ARRAS
      • Ars-Laquenexy, France
        • CHR Metz Thionville
      • Aurillac, France
        • CH Henri Mondor d'Aurillac
      • Besançon, France
        • Chu Jean Minjoz
      • Château-Thierry, France
        • Centre Hospitalier de Chateau Thierry
      • Clamart, France
        • Hopital D'Instruction Des Armees Percy
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand - Site de Gabriel Montpied - Neuroréanimation
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand - Site de Gabriel Montpied - Réa médico chir
      • Clichy, France
        • Hôpital Beaujon - Réa hépato digestive
      • Clichy, France
        • Hôpital Beaujon - Réa neuro chir
      • Dax, France
        • CH de Dax
      • Grenoble, France
        • CHU de Grenoble - Hôpital A Michallon
      • Jossigny, France
        • Hôpital privé de Marne la Vallée
      • La Rochelle, France
        • Groupe Hospitalier Littoral Atlantique
      • Laon, France
        • Centre Hospitalier de Laon - Réanimation Polyvalente
      • Le Chesnay, France
        • CH de Versailles - André Mignot
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
      • Lille, France
        • CHRU de Lille - Réa Neurochirurgicale
      • Lille, France
        • CHRU de Lille - service de déchocage et de soins intensifs - Urgence
      • Lille, France
        • CHRU de Lille- Hôpital Huriez
      • Marseille, France
        • Hopital Nord APHM
      • Marseille, France
        • CHU la Timone 2 - Pôle GEST - RUSH
      • Mont-de-Marsan, France
        • CH Mont de Marsan
      • Montpellier, France
        • CHU Montpellier - Hôpital Lapeyronie
      • Montpellier, France
        • CHU de Montpellier - Hôpital Gui de Chauliac
      • Montpellier, France
        • CHU Montpellier - Hôpital Arnaud de Villeneuve
      • Montpellier, France
        • CHU de Montpellier - Hopital Gui de Chauliac - Réa médicale
      • Montélimar, France
        • Centre Hospitalier de Montelimar
      • Mulhouse, France
        • Groupe hospitalier de la région de Mulhouse et Sud-Alsace _ GHRMSA Mulhouse
      • Nancy, France
        • CHRU de NANCY
      • Nantes, France
        • CHU Nantes, Hôtel-Dieu
      • Nice, France
        • Hôpital Pasteur 2 - CHU de Nice
      • Nice, France
        • Hôpital Privé Gériatrique Les Sources- Nice
      • Nouméa, France
        • Centre Hospitalier territorial de Nouméa en Nouvelle Calédonie
      • Nîmes, France
        • CHU de Nîmes
      • Orléans, France
        • Centre Hospitalier d'Orléans
      • Paris, France
        • Hopital Lariboisiere
      • Paris, France
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Paris, France
        • Centre Hospitalier Sainte-Anne
      • Paris, France
        • Chu Bichat Claude Bernard
      • Paris, France
        • Hôpital Pitié-Salpêtrière - Réa neuro chir
      • Paris, France
        • Hôpital Pitié-Salpêtrière - Réanimation Polyvalente
      • Paris, France
        • Hôpital Pitié-Salpêtrière Paris - SSPI
      • Paris, France
        • Hopital Saint Antoine - Paris
      • Poitiers, France
        • Chu de Poitiers
      • Reims, France
        • CHU de Reims
      • Rennes, France
        • CHU de Rennes - Réanimation chirurgicale
      • Rennes, France
        • CHU de Rennes - Réanimation CTCV
      • Romans, France
        • Hôpitaux Drôme Nord - Site de Romans
      • Rouen, France
        • CHU de ROUEN
      • Rouen, France
        • CHU Rouen - Réanimation cardiaque chirurgicale
      • Saint-Grégoire, France
        • Centre Hospitalier Prive Saint-Gregoire
      • Strasbourg, France
        • CHRU Strasbourg
      • Toulon, France
        • Hôpital d'Instruction des Armées Sainte Anne
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • CHU de Toulouse - Hôpital Pierre-Paul
      • Toulouse, France
        • CHU de Toulouse-Rangueil
      • Toulouse, France
        • CHU Rangueil - Toulouse - Réanimation de Néphrologie et Transplantation
      • Tours, France
        • CHRU Tours, Site Trousseau - Réa chir
      • Tours, France
        • CHRU Tours, Site Trousseau - URTC-B
      • Vannes, France
        • Centre Hospitalier Bretagne Atlantique de Vannes
      • Villejuif, France
        • Gustave Roussy

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
Other: NO INTERVENTION
observational study, no intervention performed

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)
Information concerning end-of-life sedative practices are recorder in the CRF (treatments used, patient's and unit characteristics...)
after patient death (before january 1st 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Anesthésie et de Réanimation

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.

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