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

Primary Purpose

COVID-19 Infection, Sars-cov-2, Respiratory Failure

Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Treatment with Dexmedetomidine
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection focused on measuring COVID-19, sars-cov-2, infection, respiratory failure, palliative situation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2020
Last Updated
August 31, 2020
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT04350086
Brief Title
Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
Acronym
PRODEX
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
unfavorable opinion of the ethics committee
Study Start Date
April 20, 2020 (Anticipated)
Primary Completion Date
November 20, 2020 (Anticipated)
Study Completion Date
November 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection, Sars-cov-2, Respiratory Failure, Palliative Situation
Keywords
COVID-19, sars-cov-2, infection, respiratory failure, palliative situation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Treatment with Dexmedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
Description
Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Overall survival of patients on Dexmedetomidine
Description
Overall survival time in days from inclusion.
Time Frame
Day 30
Title
Daily analgesic effect of Dexmedetomidine
Description
The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.
Time Frame
Day 30
Title
Other sedative pharmacological agents
Description
Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.
Time Frame
Day 30
Title
Average dosage required for Dexmedetomidine to achieve mild to moderate sedation
Description
Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major patient Relating to palliative care With sars-cov-2 infection Requiring light to moderate sedation corresponding to a RASS score of -1 to -3 Exclusion Criteria: Pregnant, lactating woman. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics Advanced heart block (level 2 or 3) unless a pacemaker. Uncontrolled hypotension. Acute cerebrovascular pathologies. Use of other sedative drugs
Facility Information:
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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