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
  Purpose

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.


Condition Intervention Phase
Postoperative
Delirium
Psychomotor
Confusion
Drug: Dexmedetomidine
Drug: Haloperidol
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-centre, Randomised, Double-blind, Placebo-controlled Comparison of Intravenous Dexmedetomidine and Haloperidol in Treatment of Psychomotor Confusion After Heart Surgery

Resource links provided by NLM:


Further study details as provided by Thorax-Kärlkliniken:

Primary Outcome Measures:
  • Need for rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: May 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Bolus and continuous infusion
Other Name: Precedex
Active Comparator: Haloperidol Drug: Haloperidol
Bolus doses
Other Name: Haldol
Placebo Comparator: Placebo Drug: Saline
Bolus and continuous infusion
Other Name: Vehicle

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140529

Locations
Sweden
ThoraxKärlkliniken
Linköping, Sweden, SE-61293
Sponsors and Collaborators
Thorax-Kärlkliniken
Investigators
Principal Investigator: Sten M Walther, MD PhD ThoraxKärlkliniken, University Hospital, Linköping, Sweden
  More Information

No publications provided

Responsible Party: Sten Walther, ThoraxKärlkliniken, Universitetssjukhuset, Linköping
ClinicalTrials.gov Identifier: NCT01140529     History of Changes
Other Study ID Numbers: 3005099
Study First Received: June 7, 2010
Last Updated: January 25, 2012
Health Authority: Sweden: Läkemedelsverket

Keywords provided by Thorax-Kärlkliniken:
Dexmedetomidine

Additional relevant MeSH terms:
Confusion
Delirium
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Dexmedetomidine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 28, 2014