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Influence of Dexmedetomidine or Propofol on ICU Delirium

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02807467
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
In this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by continuous infusions of dexmedetomidine compared to propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium, decreases the duration of delirium. The infusions might have to be repeated several times to achieve resolution of delirium.

Condition or disease Intervention/treatment Phase
Delirium Drug: Dexmedetomidine Drug: Propofol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Propofol and Dexmedetomidine to Treat Hyperactive and Mixed ICU Delirium - the Basel ProDex Randomized Trial
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Dexmedetomidine
Dexmedetomidine is a potent selective α-2-adrenergic receptor agonist frequently used for sedation in the ICU, also among critically ill patients. It promotes sedation, anxiolysis, and moderate analgesia with minimal respiratory depression and has been shown to reduce severity and duration of ICU delirium.
Drug: Dexmedetomidine
Continuous infusion of dexmedetomidine between 8pm and 6am after diagnosis of hyperactive or mixed delirium. The infusion might have to be repeated several times to achieve resolution of delirium.
Other Name: Dexdor

Active Comparator: Propofol
Standard therapy for ICU delirium.
Drug: Propofol
Continuous infusion of propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium. The infusion might have to be repeated several times to achieve resolution of delirium.
Other Name: Disoprivan




Primary Outcome Measures :
  1. Reduction of ICU delirium duration assessed by ICDSC checklist [ Time Frame: during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided ]
    The onset of delirium will be defined as the start of the first of a minimum of two subsequent shifts with an ICDSC ≥ 4 and an SAS ≥ 5. The end of the delirium will be defined as the end of the last shift with an ICDSC ≥ 4 that precedes a minimum of two subsequent shifts with an I CDSC < 4.



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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:

  • Adult patients (age 18 years or older) in a state of delirium (hyperactive ore mixed type) upon detection in the ICU (i.e., ICDSC >3).

Exclusion Criteria:

  • Hypersensitivity to the active substance
  • Advanced heart block (grade 2 or 3) unless implanted pacemaker
  • Uncontrolled hypotension
  • Acute cerebrovascular conditions
  • Severe cardiac dysfunction
  • Bradycardia
  • Egg allergy
  • Soybean/soy allergy
  • Age below 18 years
  • Terminal state
  • Pregnancy
  • Active psychosis (of non organic origin = functional disturbances)
  • Status epilepticus or postictal states following seizures on EEG
  • Delirium due to alcohol withdrawal

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): NCT02807467


Contacts
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Contact: Alexa Hollinger, MD 0041 61 328 65 08 alexa.hollinger@usb.ch
Contact: Martin Siegemund, MD 0041 61 328 64 14 martin.siegemund@usb.ch

Locations
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Switzerland
Intensive Care Units, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Alexa Hollinger, MD    0041613286508    alexa.hollinger@usb.ch   
Contact: Martin Siegemund, MD    0041613286414    martin.siegemund@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Alexa Hollinger, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02807467    
Other Study ID Numbers: Basel ProDex Study
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: anonymized data will be analyzed and published

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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, Basel, Switzerland:
reduction
delirium
duration
severity
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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
Molecular Mechanisms of Pharmacological Action