Coronary Artery Bypass Graft Triple VesselNCT02186210
Effect of Prewarming on Microcirculatory Response
A study testing prewarming in people with Coronary Artery Bypass Graft Triple Vessel, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Bypass Graft Triple Vessel
- What is being tested?
- prewarming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- off-pump coronary artery bypass surgery
Who cannot join
- refuse to enroll
- cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
- preoperative left ventricular ejection fraction < 35%
- preoperative continuous infusion of vasopressor or inotropes
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.
Read the detailed description
Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.
- Being tested
- prewarming
- Keywords
- microcirculation, off-pump coronary artery bypass surgery, tissue oxygen saturation, vascular occlusion test, recovery slope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prewarmingDevice
Also called prewarming by active air heater
recovery slope StO2
| Study group | Role | What they receive |
|---|---|---|
| prewarming | Experimental | prewarming during induction of anesthesia Receives: Device: prewarming |
| control | No intervention | no prewarming during induction of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Slope
We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
Measured: 3 hours after induction of anesthesia
Secondary outcomes (1)
Tissue Oxygen Saturation
Measured: During the surgery, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft Triple VesselStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunseok Jeon, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186210
- Sponsor's protocol ID
- Prewarming_OPCAB
- Status last verified
- Aug 2014
- First submitted
- 4 Jul 2014
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cho YJ, Lee SY, Kim TK, Hong DM, Jeon Y. Effect of Prewarming during Induction of Anesthesia on Microvascular Reactivity in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery: A Randomized Clinical Trial. PLoS One. 2016 Jul 21;11(7):e0159772. doi: 10.1371/journal.pone.0159772. eCollection 2016.
PubMed 27442052
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prewarming on Microcirculatory Response
- ClinicalTrials.gov ID
- NCT02186210
- Acronym / sponsor ID
- Prewarming_OPCAB
- Keywords
- microcirculation, off-pump coronary artery bypass surgery, tissue oxygen saturation, vascular occlusion test, recovery slope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.
Detailed description
Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prewarming | Experimental | Device: prewarmingprewarming during induction of anesthesia |
| control | No intervention | –no prewarming during induction of anesthesia |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- off-pump coronary artery bypass surgery
Key exclusion criteria (5 listed)
- refuse to enroll
- cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
- preoperative left ventricular ejection fraction < 35%
- preoperative continuous infusion of vasopressor or inotropes
- 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 |
|---|---|---|
| prewarmingAlso: prewarming by active air heaterrecovery slope StO2 | Device | prewarming |
Primary outcome
Recovery Slope
Time frame: 3 hours after induction of anesthesia
We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
1 secondary outcome
Tissue Oxygen Saturation
Time frame: During the surgery, an average of 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27442052Cho YJ, Lee SY, Kim TK, Hong DM, Jeon Y. Effect of Prewarming during Induction of Anesthesia on Microvascular Reactivity in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery: A Randomized Clinical Trial. PLoS One. 2016 Jul 21;11(7):e0159772. doi: 10.1371/journal.pone.0159772. eCollection 2016.
- 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.
Yunseok Jeon, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prewarming in people with Coronary Artery Bypass Graft Triple Vessel, run by Seoul National University 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 5 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 18 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recovery Slope (time frame: 3 hours after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186210, which also lists 1 linked publication.
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 18 Mar 2019.