Coronary Artery DiseaseNCT04627220
Effect of Intraoperative Arterial Oxygen Targets on Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin
A study testing Intraoperative Oxygenation Strategy: PaO2 200 mmHg or Greater and Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHg in people with Coronary Artery Disease, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-center randomized trial compared two intraoperative arterial oxygen tension (PaO2) target strategies in adults undergoing elective isolated coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intraoperative Oxygenation Strategy: PaO2 200 mmHg or Greater and Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Nov 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years
- Scheduled for elective isolated coronary artery bypass graft surgery
- American Society of Anesthesiologists physical status III or higher
- Left ventricular ejection fraction of 40% or greater
Who cannot join
- Valvular heart disease requiring concomitant valve surgery
- Left ventricular ejection fraction below 40%
- Hemodynamically significant arrhythmia
- Previous stroke or transient ischemic attack
- End-stage organ failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Bursa, Bursa, 16310
About this study
Official title: Effects of Two Intraoperative Arterial Oxygen Targets on Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin in Coronary Artery Bypass Graft Surgery
This single-center randomized trial compared two intraoperative arterial oxygen tension (PaO2) target strategies in adults undergoing elective isolated coronary artery bypass graft surgery. Sixty-four participants were assigned 1:1 to a higher target (PaO2 200 mmHg or greater) or a lower target (PaO2 80 to less than 200 mmHg). The study evaluated perioperative changes in thiol-disulfide homeostasis and ischemia-modified albumin.
Read the detailed description
Hyperoxemia is frequently used during cardiac surgery to reduce the risk of hypoxemia, but excessive oxygen exposure may increase oxidative stress and ischemia-reperfusion injury. In this prospective, randomized, parallel-group study, inspired oxygen concentration was adjusted intraoperatively to achieve the assigned PaO2 target. Allocation was generated by computer and concealed with sealed envelopes. The clinical team was aware of group assignment because oxygen administration had to be titrated, whereas laboratory personnel were blinded. Biomarker samples were collected before anesthesia induction, 30 minutes after aortic cross-clamp removal, at the end of surgery, and 6 hours postoperatively. Sixty-four participants were randomized (32 per group), and 59 participants were included in the final analysis.
- Conditions
- Coronary Artery Disease
- Being tested
- Intraoperative Oxygenation Strategy: PaO2 200 mmHg or Greater, Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHg
- Keywords
- coronary artery bypass grafting, arterial oxygen tension, thiol-disulfide homeostasis, ischemia-modified albumin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Oxygenation Strategy: PaO2 200 mmHg or GreaterOther
The fraction of inspired oxygen was actively titrated during anesthesia and cardiopulmonary bypass to achieve an arterial oxygen tension (PaO2) of 200 mmHg or greater. The assigned strategy was maintained intraoperatively, subject to predefined cerebral oxygen saturation safety management.
Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHgOther
The fraction of inspired oxygen was actively titrated during anesthesia and cardiopulmonary bypass to achieve an arterial oxygen tension (PaO2) from 80 to less than 200 mmHg. The assigned strategy was maintained intraoperatively, subject to predefined cerebral oxygen saturation safety management.
| Study group | Role | What they receive |
|---|---|---|
| Higher PaO2 Target (200 mmHg or Greater) | Active comparator | During anesthesia and cardiopulmonary bypass for isolated coronary artery bypass graft surgery, the fraction of inspired oxygen was adjusted to maintain arterial oxygen tension (PaO2) at 200 mmHg or greater. Cerebral oxygen saturation was monitored, and inspired oxygen could be increased for safety if regional cerebral oxygen saturation fell below 45%. Receives: Other: Intraoperative Oxygenation Strategy: PaO2 200 mmHg or Greater |
| Lower PaO2 Target (80 to Less Than 200 mmHg) | Experimental | During anesthesia and cardiopulmonary bypass for isolated coronary artery bypass graft surgery, the fraction of inspired oxygen was adjusted to maintain arterial oxygen tension (PaO2) from 80 to less than 200 mmHg. Cerebral oxygen saturation was monitored, and inspired oxygen could be increased for safety if regional cerebral oxygen saturation fell below 45%. Receives: Other: Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Native Thiol Concentration
Serum native thiol concentration measured by the automated spectrophotometric thiol-disulfide homeostasis method and reported in micromoles per liter (micromol/L).
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Total Thiol Concentration
Serum total thiol concentration measured by the automated spectrophotometric thiol-disulfide homeostasis method and reported in micromoles per liter (micromol/L).
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Disulfide Concentration
Serum disulfide concentration calculated as one half of the difference between total thiol and native thiol concentrations and reported in micromoles per liter (micromol/L).
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Disulfide-to-Native Thiol Ratio
The ratio of serum disulfide concentration to native thiol concentration, calculated and reported as a percentage.
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Disulfide-to-Total Thiol Ratio
The ratio of serum disulfide concentration to total thiol concentration, calculated and reported as a percentage.
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Native Thiol-to-Total Thiol Ratio
The ratio of serum native thiol concentration to total thiol concentration, calculated and reported as a percentage.
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Secondary outcomes (1)
Ischemia-Modified Albumin Level
Serum ischemia-modified albumin measured using the albumin cobalt-binding assay and reported in absorbance units (ABSU).
Measured: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jan 2020
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two intraoperative arterial oxygen target strategies.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Umran Karaca, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ümran K Karaca, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research HospitalTuğba O Onur, MD, Study director, Bursa Yuksek Ihtisas Training and Research HospitalŞeyda Ö Özgünay, MD, Study director, Bursa Yuksek Ihtisas Training and Research HospitalFiliz A Ata, MD, Study director, Bursa Yuksek Ihtisas Training and Research HospitalCanan Y Yılmaz, MD, Study director, Bursa Yuksek Ihtisas Training and Research HospitalŞermin E Eminoğlu, MD, Study director, Bursa Yuksek Ihtisas Training and Research HospitalHalil Erkan S Sayan, MD, Study director, Bursa Yuksek Ihtisas Training and Research HospitalYasemin Ü Üstündağ, MD, Study director, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627220
- Sponsor's protocol ID
- 2011-KAEK-25 2019/12-21
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Intraoperative Arterial Oxygen Targets on Thiol-Disulfide Homeostasis and Ischemia-Modified Albumin in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT04627220
- Acronym / sponsor ID
- 2011-KAEK-25 2019/12-21
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass grafting, arterial oxygen tension, thiol-disulfide homeostasis, ischemia-modified albumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Nov 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.
This single-center randomized trial compared two intraoperative arterial oxygen tension (PaO2) target strategies in adults undergoing elective isolated coronary artery bypass graft surgery. Sixty-four participants were assigned 1:1 to a higher target (PaO2 200 mmHg or greater) or a lower target (PaO2 80 to less than 200 mmHg). The study evaluated perioperative changes in thiol-disulfide homeostasis and ischemia-modified albumin.
Detailed description
Hyperoxemia is frequently used during cardiac surgery to reduce the risk of hypoxemia, but excessive oxygen exposure may increase oxidative stress and ischemia-reperfusion injury. In this prospective, randomized, parallel-group study, inspired oxygen concentration was adjusted intraoperatively to achieve the assigned PaO2 target. Allocation was generated by computer and concealed with sealed envelopes. The clinical team was aware of group assignment because oxygen administration had to be titrated, whereas laboratory personnel were blinded. Biomarker samples were collected before anesthesia induction, 30 minutes after aortic cross-clamp removal, at the end of surgery, and 6 hours postoperatively. Sixty-four participants were randomized (32 per group), and 59 participants were included in the final analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two intraoperative arterial oxygen target strategies.
| Arm | Type | Receives |
|---|---|---|
| Higher PaO2 Target (200 mmHg or Greater) | Active comparator | Other: Intraoperative Oxygenation Strategy: PaO2 200 mmHg or GreaterDuring anesthesia and cardiopulmonary bypass for isolated coronary artery bypass graft surgery, the fraction of inspired oxygen was adjusted to maintain arterial oxygen tension (PaO2) at 200 mmHg or greater. Cerebral oxygen saturation was monitored, and inspired oxygen could be increased for safety if regional cerebral oxygen saturation fell below 45%. |
| Lower PaO2 Target (80 to Less Than 200 mmHg) | Experimental | Other: Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHgDuring anesthesia and cardiopulmonary bypass for isolated coronary artery bypass graft surgery, the fraction of inspired oxygen was adjusted to maintain arterial oxygen tension (PaO2) from 80 to less than 200 mmHg. Cerebral oxygen saturation was monitored, and inspired oxygen could be increased for safety if regional cerebral oxygen saturation fell below 45%. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years
- Scheduled for elective isolated coronary artery bypass graft surgery
- American Society of Anesthesiologists physical status III or higher
- Left ventricular ejection fraction of 40% or greater
Key exclusion criteria (5 listed)
- Valvular heart disease requiring concomitant valve surgery
- Left ventricular ejection fraction below 40%
- Hemodynamically significant arrhythmia
- Previous stroke or transient ischemic attack
- End-stage organ failure
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 |
|---|---|---|
| Intraoperative Oxygenation Strategy: PaO2 200 mmHg or GreaterThe fraction of inspired oxygen was actively titrated during anesthesia and cardiopulmonary bypass to achieve an arterial oxygen tension (PaO2) of 200 mmHg or greater. The assigned strategy was maintained intraoperatively, subject to predefined cerebral oxygen saturation safety management. | Other | Higher PaO2 Target (200 mmHg or Greater) |
| Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHgThe fraction of inspired oxygen was actively titrated during anesthesia and cardiopulmonary bypass to achieve an arterial oxygen tension (PaO2) from 80 to less than 200 mmHg. The assigned strategy was maintained intraoperatively, subject to predefined cerebral oxygen saturation safety management. | Other | Lower PaO2 Target (80 to Less Than 200 mmHg) |
Primary outcome
Native Thiol Concentration
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Serum native thiol concentration measured by the automated spectrophotometric thiol-disulfide homeostasis method and reported in micromoles per liter (micromol/L).
Total Thiol Concentration
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Serum total thiol concentration measured by the automated spectrophotometric thiol-disulfide homeostasis method and reported in micromoles per liter (micromol/L).
Disulfide Concentration
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
Serum disulfide concentration calculated as one half of the difference between total thiol and native thiol concentrations and reported in micromoles per liter (micromol/L).
Disulfide-to-Native Thiol Ratio
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
The ratio of serum disulfide concentration to native thiol concentration, calculated and reported as a percentage.
Disulfide-to-Total Thiol Ratio
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
The ratio of serum disulfide concentration to total thiol concentration, calculated and reported as a percentage.
Native Thiol-to-Total Thiol Ratio
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
The ratio of serum native thiol concentration to total thiol concentration, calculated and reported as a percentage.
1 secondary outcome
Ischemia-Modified Albumin Level
Time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively
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 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ümran K Karaca, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
Tuğba O Onur, MD study director
Bursa Yuksek Ihtisas Training and Research Hospital
Şeyda Ö Özgünay, MD study director
Bursa Yuksek Ihtisas Training and Research 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 Intraoperative Oxygenation Strategy: PaO2 200 mmHg or Greater and Intraoperative Oxygenation Strategy: PaO2 80 to Less Than 200 mmHg in people with Coronary Artery Disease, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 24 Sep 2026. 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 Turkey (Türkiye). 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?
Native Thiol Concentration (time frame: Before anesthesia induction; 30 minutes after aortic cross-clamp removal; at the end of surgery; and 6 hours postoperatively). The study lists 6 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 24 Sep 2026.