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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2023 |
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Main ID: |
NCT02807467 |
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Date of registration:
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09/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Influence of Dexmedetomidine or Propofol on ICU Delirium
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Scientific title:
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Comparison of Propofol and Dexmedetomidine to Treat Hyperactive and Mixed ICU Delirium - the Basel ProDex Randomized Trial |
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Date of first enrolment:
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March 1, 2019 |
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Target sample size:
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37 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02807467 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Alexa Hollinger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Basel, Switzerland |
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Key inclusion & exclusion criteria
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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
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Delirium
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Intervention(s)
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Drug: Propofol
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Drug: Dexmedetomidine
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Primary Outcome(s)
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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]
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Secondary ID(s)
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Basel ProDex Study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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