NCT05108792

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
585

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

64 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

October 14, 2021

Last Update Submit

November 4, 2021

Conditions

Keywords

Limit or Stop Treatment in Intensive CareContinuous deep sedation (CDS)Continuous deep sedation until death (CDSUD)

Outcome Measures

Primary Outcomes (1)

  • Description of end-of-life sedative practices

    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)

Study Arms (1)

Patients deceased following a decision to limit or stop therapeutics

a

Other: NO INTERVENTION

Interventions

observational study, no intervention performed

Patients deceased following a decision to limit or stop therapeutics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (64)

CHU Amiens

Amiens, France

Location

CHU Angers

Angers, France

Location

CH Arras

Arras, France

Location

CHR Metz Thionville

Ars-Laquenexy, France

Location

CH Henri Mondor d'Aurillac

Aurillac, France

Location

CHU Jean Minjoz

Besançon, France

Location

Centre Hospitalier de Chateau Thierry

Château-Thierry, France

Location

Hôpital d'Instruction des Armées Percy

Clamart, France

Location

CHU Clermont-Ferrand - Site de Gabriel Montpied - Neuroréanimation

Clermont-Ferrand, France

Location

CHU Clermont-Ferrand - Site de Gabriel Montpied - Réa médico chir

Clermont-Ferrand, France

Location

Hôpital Beaujon - Réa hépato digestive

Clichy, France

Location

Hôpital Beaujon - Réa neuro chir

Clichy, France

Location

CH de DAX

Dax, France

Location

CHU de Grenoble - Hôpital A Michallon

Grenoble, France

Location

Hôpital privé de Marne la Vallée

Jossigny, France

Location

Groupe Hospitalier LITTORAL ATLANTIQUE

La Rochelle, France

Location

Centre Hospitalier de Laon - Réanimation Polyvalente

Laon, France

Location

CH de Versailles - André Mignot

Le Chesnay, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

CHRU de Lille - Réa Neurochirurgicale

Lille, France

Location

CHRU de Lille - service de déchocage et de soins intensifs - Urgence

Lille, France

Location

CHRU de Lille- Hôpital Huriez

Lille, France

Location

CHU la Timone 2 - Pôle GEST - RUSH

Marseille, France

Location

Hôpital Nord Aphm

Marseille, France

Location

CH Mont de Marsan

Mont-de-Marsan, France

Location

Centre Hospitalier de Montélimar

Montélimar, France

Location

CHU de Montpellier - Hopital Gui de Chauliac - Réa médicale

Montpellier, France

Location

CHU de Montpellier - Hopital Gui de Chauliac

Montpellier, France

Location

CHU MONTPELLIER - Hôpital Arnaud de Villeneuve

Montpellier, France

Location

CHU Montpellier - Hôpital Lapeyronie

Montpellier, France

Location

Groupe hospitalier de la région de Mulhouse et Sud-Alsace _ GHRMSA Mulhouse

Mulhouse, France

Location

CHRU de NANCY

Nancy, France

Location

CHU Nantes, Hôtel-Dieu

Nantes, France

Location

Hôpital Pasteur 2 - CHU de Nice

Nice, France

Location

Hôpital Privé Gériatrique Les Sources- Nice

Nice, France

Location

CHU de Nimes

Nîmes, France

Location

Centre Hospitalier territorial de Nouméa en Nouvelle Calédonie

Nouméa, France

Location

Centre Hospitalier d'Orléans

Orléans, France

Location

Centre Hospitalier Sainte-Anne

Paris, France

Location

CHU Bichat Claude Bernard

Paris, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Location

Hôpital Lariboisière

Paris, France

Location

Hôpital Pitié-Salpêtrière - Réa neuro chir

Paris, France

Location

Hôpital Pitié-Salpêtrière - Réanimation Polyvalente

Paris, France

Location

Hôpital Pitié-Salpêtrière Paris - SSPI

Paris, France

Location

hôpital Saint Antoine - Paris

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Reims

Reims, France

Location

CHU de Rennes - Réanimation chirurgicale

Rennes, France

Location

CHU de Rennes - Réanimation CTCV

Rennes, France

Location

Hôpitaux Drôme Nord - Site de Romans

Romans, France

Location

CHU de Rouen

Rouen, France

Location

CHU Rouen - Réanimation cardiaque chirurgicale

Rouen, France

Location

Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, France

Location

CHRU Strasbourg

Strasbourg, France

Location

Hôpital d'Instruction des Armées Sainte Anne

Toulon, France

Location

CHU de Toulouse - Hôpital Pierre-Paul

Toulouse, France

Location

CHU de Toulouse-Rangueil

Toulouse, France

Location

CHU Rangueil - Toulouse - Réanimation de Néphrologie et Transplantation

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

CHRU Tours, Site Trousseau - Réa chir

Tours, France

Location

CHRU Tours, Site Trousseau - URTC-B

Tours, France

Location

Centre Hospitalier Bretagne Atlantique de Vannes

Vannes, France

Location

Gustave Roussy

Villejuif, France

Location

Study Officials

  • Matthieu LE DORZE, MD

    GH Lariboisière-St Louis

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 5, 2021

Study Start

February 26, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Locations