PostoperativePhase 3DexinDelirNCT01140529
Dexmedetomidine for the Treatment of Delirium After Heart Surgery
A Phase 3 study testing Dexmedetomidine, Haloperidol and Saline in people with Postoperative and Delirium, run by Thorax-Kärlkliniken at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative, Delirium, Psychomotor
- What is being tested?
- Dexmedetomidine, Haloperidol and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Postoperative, Delirium, Psychomotor, Confusion
- Being tested
- Dexmedetomidine, Haloperidol, Saline
- Keywords
- Dexmedetomidine
- Medical subject headings
- Delirium, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Bolus and continuous infusion
HaloperidolDrug
Also called Haldol
Bolus doses
SalineDrug
Also called Vehicle
Bolus and continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Haloperidol | Active comparator | Not described Receives: Drug: Haloperidol |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for rescue medication
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionJun 2012
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorax-Kärlkliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sten Walther, Thorax-Kärlkliniken
- Investigators
- Sten M Walther, MD PhD, Principal investigator, ThoraxKärlkliniken, University Hospital, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140529
- Sponsor's protocol ID
- 3005099
- Acronym
- DexinDelir
- Status last verified
- Oct 2016
- First submitted
- 7 Jun 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01140529
- Acronym / sponsor ID
- DexinDelir / 3005099
- Conditions
- Postoperative, Delirium, Psychomotor, Confusion
- Keywords
- Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Thorax-KärlklinikenUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Haloperidol | Active comparator | Drug: Haloperidol |
| Placebo | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexBolus and continuous infusion | Drug | Dexmedetomidine |
| HaloperidolAlso: HaldolBolus doses | Drug | Haloperidol |
| SalineAlso: VehicleBolus and continuous infusion | Drug | Placebo |
Primary outcome
Need for rescue medication
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten M Walther, MD PhD principal investigator
ThoraxKärlkliniken, University Hospital, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine, Haloperidol and Saline in people with Postoperative and Delirium, run by Thorax-Kärlkliniken at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for rescue medication (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.