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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hôpital d'instruction des armées 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
        • Hôpital Lariboisière
      • 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 Privé Saint-Grégoire
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société Française d'Anesthésie et de Réanimation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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