Chronic Dissecting Aneurysm of Thoracic AortaPhase 4NCT02678728
Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
A Phase 4 study testing Dexmedetomidine and normal saline in people with Chronic Dissecting Aneurysm of Thoracic Aorta and Chronic Nontraumatic Dissection of Thoracic Aorta, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. The investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with… Read more about this study
- Who is it for?
- Ages 20 to 98 years
- Conditions the study is for
- Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta, Dissecting Aneurysm of the Thoracic Aorta
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to 30 Mar 2018
- Phase
- Phase 4
- 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 20 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age
Who cannot join
- Unstable vital sign before surgery
- Severe pulmonary disease requiring consistent treatment
- Illiterate
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. The investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with systemic inflammatory response, and oxidative stress.
Read the detailed description
Patients will be divided into 2 groups; dexmedetomidine group and control group. Dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery. And control group will receive the same amount of normal saline instead. Analyzing patients lung function and serum factors, which indicates the degree of systemic inflammatory responses and oxidative stress, The investigators will investigate the protective effect of dexmedetomidine on lung.
- Conditions
- Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta, Dissecting Aneurysm of the Thoracic Aorta
- Being tested
- Dexmedetomidine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off
normal salineDrug
IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off Receives: Drug: Dexmedetomidine |
| Normal saline | Placebo comparator | IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of lung oxygenation from baseline to 24 hr after reperfusion
Lung oxygenation will be assessed by arterial blood gas analysis
Measured: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Changes of lung compliance from baseline to 24 hr after reperfusion
Lung compliance will be displayed on the ventilator
Measured: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion28 Feb 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Dissecting Aneurysm of Thoracic AortaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678728
- Sponsor's protocol ID
- 3-2015-0252
- Status last verified
- Aug 2019
- First submitted
- 19 Jan 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02678728
- Acronym / sponsor ID
- 3-2015-0252
- Conditions
- Chronic Dissecting Aneurysm of Thoracic Aorta, Chronic Nontraumatic Dissection of Thoracic Aorta, Dissecting Aneurysm of the Thoracic Aorta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 10 Feb 2016 (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.
Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. The investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with systemic inflammatory response, and oxidative stress.
Detailed description
Patients will be divided into 2 groups; dexmedetomidine group and control group. Dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery. And control group will receive the same amount of normal saline instead. Analyzing patients lung function and serum factors, which indicates the degree of systemic inflammatory responses and oxidative stress, The investigators will investigate the protective effect of dexmedetomidine on lung.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off |
| Normal saline | Placebo comparator | Drug: normal salineIV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off |
Who may qualify
- Ages
- 20 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age
Key exclusion criteria (4 listed)
- Unstable vital sign before surgery
- Severe pulmonary disease requiring consistent treatment
- Illiterate
- Pregnancy
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: precedex1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off | Drug | Dexmedetomidine |
| normal salineIV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off | Drug | Normal saline |
Primary outcome
Changes of lung oxygenation from baseline to 24 hr after reperfusion
Time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Lung oxygenation will be assessed by arterial blood gas analysis
Changes of lung compliance from baseline to 24 hr after reperfusion
Time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr
Lung compliance will be displayed on the ventilator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and normal saline in people with Chronic Dissecting Aneurysm of Thoracic Aorta and Chronic Nontraumatic Dissection of Thoracic Aorta, run by Gangnam Severance Hospital at 1 site in South Korea.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 14 Aug 2019. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of lung oxygenation from baseline to 24 hr after reperfusion (time frame: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr). The study lists 2 primary outcomes in all. 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 14 Aug 2019.