Cerebral Oxygen SaturationNCT04214145
The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG
A study testing Phenylephrine, Norepinephrine and Vasopressin in people with Cerebral Oxygen Saturation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cerebral Oxygen Saturation
- What is being tested?
- Phenylephrine, Norepinephrine and Vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2020to 3 Sep 2021
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing off pump coronary artery bypass.
Who cannot join
- Patient refusal
- Preoperative vasopressor use
- Preoperative mechanical circulatory support
- Concurrent cerebrovascular or head and neck surgery
- Technical difficulty of measuring brain oxygen saturation
- Redo coronary artery bypass surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, 03080
About this study
Official title: The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study
The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.
- Conditions
- Cerebral Oxygen Saturation
- Being tested
- Phenylephrine, Norepinephrine, Vasopressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg * 5@ + D5W 200 mL) if mean BP < 60mmHg.
- Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr)
- Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes
- Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)
NorepinephrineDrug
Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg * 1@ + D5W 200 mL) if mean BP < 60mmHg.
- Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr)
- Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes
- Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)
VasopressinDrug
Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u * 1@ + D5W 200 mL) if mean BP < 60mmHg.
- Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr)
- Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes
- Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Not described Receives: Drug: Phenylephrine |
| Norepinephrine | Experimental | Not described Receives: Drug: Norepinephrine |
| Vasopressin | Experimental | Not described Receives: Drug: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygen saturation (%)
continuous monitoring of cerebral oxygen saturation during surgery
Measured: during surgery
Secondary outcomes (14)
blood pressure
systolic/diastolic/mean blood pressure(mmHg)
Measured: during surgery
heart rate
heart rate(/min)
Measured: during surgery
cardiac index
cardiac index (L/min)
Measured: during surgery
Total amount of infused drug
Propofol, remifentanil, vasoacitve drugs
Measured: during surgery
Input/output
Urine output, blood loss, amount of fluid and transfusion
Measured: during surgery
Sublingual microscopy
using SDF imaging device
Measured: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
Vascular occlusion test
using InspectraTM StO2
Measured: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
Troponin I
Troponin I (ng/mL)
Measured: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
lactate
lactate (mmol/L)
Measured: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
creatinine
creatinine (mg/dL)
Measured: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
albumin
albumin (g/dL)
Measured: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
NGAL
NGAL (ng/mL)
Measured: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
MACCE
Major adverse cardiac and cerebrovascular events
Measured: until 1 year after surgery
AKI/RRT
renal complication
Measured: until 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start7 Jan 2020
- Primary completion2 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Oxygen SaturationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214145
- Sponsor's protocol ID
- OPCAB_vasopressor
- Status last verified
- May 2022
- First submitted
- 22 Dec 2019
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study
- ClinicalTrials.gov ID
- NCT04214145
- Acronym / sponsor ID
- OPCAB_vasopressor
- Conditions
- Cerebral Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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.
The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.
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 |
|---|---|---|
| Phenylephrine | Experimental | Drug: Phenylephrine |
| Norepinephrine | Experimental | Drug: Norepinephrine |
| Vasopressin | Experimental | Drug: Vasopressin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing off pump coronary artery bypass.
Key exclusion criteria (6 listed)
- Patient refusal
- Preoperative vasopressor use
- Preoperative mechanical circulatory support
- Concurrent cerebrovascular or head and neck surgery
- Technical difficulty of measuring brain oxygen saturation
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 |
|---|---|---|
| PhenylephrineContinuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg * 5@ + D5W 200 mL) if mean BP < 60mmHg. 1. Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr) 2. Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes 3. Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr) | Drug | Phenylephrine |
| NorepinephrineContinuous infusion of Norepienphrine 20 μg/mL (=NE 4mg * 1@ + D5W 200 mL) if mean BP < 60mmHg. 1. Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr) 2. Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes 3. Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr) | Drug | Norepinephrine |
| VasopressinContinuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u * 1@ + D5W 200 mL) if mean BP < 60mmHg. 1. Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr) 2. Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes 3. Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr) | Drug | Vasopressin |
Primary outcome
Cerebral oxygen saturation (%)
Time frame: during surgery
continuous monitoring of cerebral oxygen saturation during surgery
14 secondary outcomes
blood pressure
Time frame: during surgery
heart rate
Time frame: during surgery
cardiac index
Time frame: during surgery
Total amount of infused drug
Time frame: during surgery
Input/output
Time frame: during surgery
Sublingual microscopy
Time frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
Vascular occlusion test
Time frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
Troponin I
Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
lactate
Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
creatinine
Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
albumin
Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
NGAL
Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
MACCE
Time frame: until 1 year after surgery
AKI/RRT
Time frame: until 1 year after surgery
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 9 May 2022.
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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.
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 study testing Phenylephrine, Norepinephrine and Vasopressin in people with Cerebral Oxygen Saturation, 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 6 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 9 May 2022. 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?
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?
Cerebral oxygen saturation (%) (time frame: during surgery). 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 9 May 2022.