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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04350086
Recruitment Status : Withdrawn (unfavorable opinion of the ethics committee)
First Posted : April 16, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Infection Sars-cov-2 Respiratory Failure Palliative Situation Drug: Treatment with Dexmedetomidine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 20, 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival of patients on Dexmedetomidine [ Time Frame: Day 30 ]
    Overall survival time in days from inclusion.

  2. 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.

  3. 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.

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350086


Locations
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France
University Hospital
Limoges, France, 87200
Sponsors and Collaborators
University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04350086    
Other Study ID Numbers: 87RI20_0011 (PRODEX)
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
COVID-19
sars-cov-2
infection
respiratory failure
palliative situation
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents