Dexmedetomidine for the Treatment of Delirium After Heart Surgery (DexinDelir)

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by:
Thorax-Kärlkliniken
ClinicalTrials.gov Identifier:
NCT01140529
First received: June 7, 2010
Last updated: January 25, 2012
Last verified: March 2010

June 7, 2010
January 25, 2012
May 2010
May 2012   (final data collection date for primary outcome measure)
Need for rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140529 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Dexmedetomidine for the Treatment of Delirium After Heart Surgery
A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery

Primary hypothesis: Dexmedetomidine is equal or superior to haloperidol and placebo in the treatment of psychomotor confusion in patients who are recovering from heart surgery.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Postoperative
  • Delirium
  • Psychomotor
  • Confusion
  • Drug: Dexmedetomidine
    Bolus and continuous infusion
    Other Name: Precedex
  • Drug: Haloperidol
    Bolus doses
    Other Name: Haldol
  • Drug: Saline
    Bolus and continuous infusion
    Other Name: Vehicle
  • Experimental: Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Haloperidol
    Intervention: Drug: Haloperidol
  • Placebo Comparator: Placebo
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
June 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 65 years
  • 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:

  • Ongoing neuroleptic, propofol and α2 agonist medication
  • 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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01140529
3005099
No
Sten Walther, ThoraxKärlkliniken, Universitetssjukhuset, Linköping
Thorax-Kärlkliniken
Not Provided
Principal Investigator: Sten M Walther, MD PhD ThoraxKärlkliniken, University Hospital, Linköping, Sweden
Thorax-Kärlkliniken
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP