Continuous Deep Sedation Until Death

Terminal Care Clinical Trial

— SPCMD-REA  

Official title:

Continuous Deep Sedation Until Death Following a Decision to Limit or Stop Treatment in Intensive Care and in Continuous Surveillance Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108792
• Other study ID #: SPCMD-REA / NR 2020-01
• Status: Completed
• Start date: February 26, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Société Française d'Anesthésie et de Réanimation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Terminal Care

Intervention

Other:
• NO INTERVENTION
observational study, no intervention performed

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)