Dexmedetomidine for the Treatment of Delirium After Heart Surgery
NCT ID: NCT01140529
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
3 participants
INTERVENTIONAL
2010-05-31
2012-06-30
Brief Summary
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Study design:
Multi-centre, prospective, randomised, placebo-controlled double-blind study of dexmedetomidine vs. haloperidol for treatment of psychomotor confusion after cardiac surgery. Data will be analyzed in two steps: The primary comparison is between placebo and dexmedetomidine. If the effect of dexmedetomidine is significant, a secondary comparison between dexmedetomidine and haloperidol will follow.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexmedetomidine
Dexmedetomidine
Bolus and continuous infusion
Haloperidol
Haloperidol
Bolus doses
Placebo
Saline
Bolus and continuous infusion
Interventions
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Dexmedetomidine
Bolus and continuous infusion
Haloperidol
Bolus doses
Saline
Bolus and continuous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical need for treatment of psychomotor confusion unresponsive to standard analgesic medication (RASS +2 to +3)
* Heart surgery and extracorporeal circulation (ECC) within 7 days
* Written informed consent obtained before surgery
* Mentally competent at the time of written informed consent
Exclusion Criteria
* Intubated patient
* Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure \< 55 mmHg despite volume, vasopressors and IABP)
* Severe bradycardia without pacemaker backup (heart rate \< 50 beats/min)
* AV-conduction block II-III (without pacemaker backup)
* Severe hepatic impairment (Serum bilirubin \> 101 µmol/l)
* Lithium therapy
65 Years
ALL
No
Sponsors
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Thorax-Kärlkliniken
OTHER
Responsible Party
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Sten Walther
Dr
Principal Investigators
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Sten M Walther, MD PhD
Role: PRINCIPAL_INVESTIGATOR
ThoraxKärlkliniken, University Hospital, Linköping, Sweden
Locations
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ThoraxKärlkliniken, Universitetssjukhuset
Linköping, , Sweden
Countries
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Other Identifiers
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3005099
Identifier Type: -
Identifier Source: org_study_id