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
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Drug: Dexmedetomidine Drug: Propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||318 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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
- 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.
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
|Contact: Alexa Hollinger, MD||0041 61 328 65 email@example.com|
|Contact: Martin Siegemund, MD||0041 61 328 64 firstname.lastname@example.org|
|Principal Investigator:||Alexa Hollinger, MD||University Hospital, Basel, Switzerland|