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Clinical trial

Comparison of Propofol and Dexmedetomidine to Treat Hyperactive and Mixed ICU Delirium - the Basel ProDex Randomized Trial

ID
Name
Basel ProDex Study
Description
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.
Trial arms
Trial start
2019-03-01
Estimated PCD
2022-03-03
Trial end
2023-02-11
Status
Terminated
Phase
Early phase I
Treatment
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.
Arms:
Dexmedetomidine
Other names:
Dexdor
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.
Arms:
Propofol
Other names:
Disoprivan
Size
37
Primary endpoint
Reduction of ICU delirium duration assessed by ICDSC checklist
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
Eligibility 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 * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}
Updated at
2023-06-06

1 organization

2 products

1 indication

Organization
University Hospital Basel
Product
Dexmedetomidine
Indication
Delirium
Product
Propofol