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

Primary Purpose

Postoperative, Delirium, Psychomotor

Status
Terminated
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Dexmedetomidine
Haloperidol
Saline
Sponsored by
Thorax-Kärlkliniken
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative focused on measuring Dexmedetomidine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ThoraxKärlkliniken, Universitetssjukhuset

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

Haloperidol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Need for rescue medication

Secondary Outcome Measures

Full Information

First Posted
June 7, 2010
Last Updated
October 29, 2016
Sponsor
Thorax-Kärlkliniken
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1. Study Identification

Unique Protocol Identification Number
NCT01140529
Brief Title
Dexmedetomidine for the Treatment of Delirium After Heart Surgery
Acronym
DexinDelir
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thorax-Kärlkliniken

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative, Delirium, Psychomotor, Confusion
Keywords
Dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Title
Haloperidol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Bolus and continuous infusion
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
Bolus doses
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Vehicle
Intervention Description
Bolus and continuous infusion
Primary Outcome Measure Information:
Title
Need for rescue medication
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sten M Walther, MD PhD
Organizational Affiliation
ThoraxKärlkliniken, University Hospital, Linköping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
ThoraxKärlkliniken, Universitetssjukhuset
City
Linköping
ZIP/Postal Code
SE-58185
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Dexmedetomidine for the Treatment of Delirium After Heart Surgery

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