Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection (PRODEX)

August 31, 2020 updated by: University Hospital, Limoges

Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection

The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.

Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.

The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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
      • Limoges, France, 87200
        • University Hospital

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

Description

Inclusion Criteria:

  1. Major patient
  2. Relating to palliative care
  3. With sars-cov-2 infection
  4. Requiring light to moderate sedation corresponding to a RASS score of -1 to -3

Exclusion Criteria:

  1. Pregnant, lactating woman.
  2. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics
  3. Advanced heart block (level 2 or 3) unless a pacemaker.
  4. Uncontrolled hypotension.
  5. Acute cerebrovascular pathologies.
  6. Use of other sedative drugs

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental arm
Drug: Treatment with Dexmedetomidine
Administration of Dexmedetomidine in continuous infusion by electric syringe pump at a dose of 0.4 µg / kg / h, with dose adjustment according to the sedation score and tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
Time Frame: Day 30
Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival of patients on Dexmedetomidine
Time Frame: Day 30
Overall survival time in days from inclusion.
Day 30
Daily analgesic effect of Dexmedetomidine
Time Frame: Day 30
The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.
Day 30
Other sedative pharmacological agents
Time Frame: Day 30
Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.
Day 30
Average dosage required for Dexmedetomidine to achieve mild to moderate sedation
Time Frame: Day 30
Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation
Day 30

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

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 (ANTICIPATED)

April 20, 2020

Primary Completion (ANTICIPATED)

November 20, 2020

Study Completion (ANTICIPATED)

November 20, 2020

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (ACTUAL)

April 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI20_0011 (PRODEX)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Respiratory Failure

Clinical Trials on Treatment with Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe