Heart Valve DiseaseNCT03012997
Effects of Hyperoxia on Open Heart Surgery
A study testing Fraction of inspired oxygen 40% and Fraction of inspired oxygen 100% in people with Heart Valve Disease and Coronary (Artery) Disease, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results)… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Heart Valve Disease, Coronary (Artery) Disease
- What is being tested?
- Fraction of inspired oxygen 40% and Fraction of inspired oxygen 100%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Dec 2016to Apr 2017
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II-III
- Patients with EF higher than 50%.
- patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)
Who cannot join
- patients with Diabetes Mellitus
- patients with COPD
- Patients with Cerebral Vascular Disease
- Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and hypercarbia (PaCO2 higher than 45 mmHg)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Kartal Kosuyolu Training and Research Hospital
Istanbul, Marmara, 35000
- Recruiting
Kartal Kosuyolu Training and Research Hospital
Istanbul
emre gurcu, Specialist, 905058917800, emregurcu@gmail.com
About this study
Official title: Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.
Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.
- Conditions
- Heart Valve Disease, Coronary (Artery) Disease
- Being tested
- Fraction of inspired oxygen 40%, Fraction of inspired oxygen 100%
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraction of inspired oxygen 40%Other
Fraction of inspired oxygen 100%Other
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: 40% oxygen | Active comparator | Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit. Receives: Other: Fraction of inspired oxygen 40% |
| Active Comparator: 100% oxygen | Active comparator | Patients in this group will be ventilated with fraction of inspired oxygen during 100% induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit. Receives: Other: Fraction of inspired oxygen 100% |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated
Measured: 72 hours
Secondary outcomes (8)
Partial pressure of oxygen(mmHg),
Partial pressure of oxygen(mmHg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
Partial pressure of carbondioxide(mm Hg)
,Partial pressure of carbondioxide(mm Hg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
lactate (mmol/l)
lactate (mmol/l) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
ph values
ph values in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
systolic arterial pressure (mmHg),
systolic arterial pressure (mmHg), levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
diastolic arterial pressure (mmHg)
diastolic arterial pressure (mmHg) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
Oxygen saturation (%)
Oxygen saturation (%) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
Measured: 72 hours
heart rate (beat/min)
heart rate (beat/min) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
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 posted6 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Koşuyolu Kartal Heart Training and Research Hospital
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
- Investigators
- Guniz Koksal, Professor, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012997
- Sponsor's protocol ID
- KK01
- Status last verified
- Jan 2017
- First submitted
- 9 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21.
PubMed 27001081
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT03012997
- Acronym / sponsor ID
- KK01
- Conditions
- Heart Valve Disease, Coronary (Artery) Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Koşuyolu Kartal Heart Training and Research Hospital
- Study start
- Dec 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 6 Jan 2017 (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.
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.
Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: 40% oxygen | Active comparator | Other: Fraction of inspired oxygen 40%Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit. |
| Active Comparator: 100% oxygen | Active comparator | Other: Fraction of inspired oxygen 100%Patients in this group will be ventilated with fraction of inspired oxygen during 100% induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA II-III
- Patients with EF higher than 50%.
- patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)
Key exclusion criteria (4 listed)
- patients with Diabetes Mellitus
- patients with COPD
- Patients with Cerebral Vascular Disease
- Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and hypercarbia (PaCO2 higher than 45 mmHg)
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 |
|---|---|---|
| Fraction of inspired oxygen 40% | Other | Active Comparator: 40% oxygen |
| Fraction of inspired oxygen 100% | Other | Active Comparator: 100% oxygen |
Primary outcome
change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
Time frame: 72 hours
As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated
8 secondary outcomes
Partial pressure of oxygen(mmHg),
Time frame: 72 hours
Partial pressure of carbondioxide(mm Hg)
Time frame: 72 hours
lactate (mmol/l)
Time frame: 72 hours
ph values
Time frame: 72 hours
systolic arterial pressure (mmHg),
Time frame: 72 hours
diastolic arterial pressure (mmHg)
Time frame: 72 hours
Oxygen saturation (%)
Time frame: 72 hours
heart rate (beat/min)
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Background: PubMed 27001081Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21.
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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.
Guniz Koksal, Professor study director
Istanbul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraction of inspired oxygen 40% and Fraction of inspired oxygen 100% in people with Heart Valve Disease and Coronary (Artery) Disease, run by Istanbul University at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guniz Koksal, Professor (05322067777, gunizkoksal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass (time frame: 72 hours). 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 NCT03012997, 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 6 Jan 2017.