Cardiac SurgeryNCT03601364
The Effects of Peep and Tidal Volume on Oxidative Stress in Cardiopulmonary Bypass Surgery
An observational study of Cardiac Surgery and Oxidative Stress, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have been reported to be directly related to this practice.Mechanisms explaining this… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Oxidative Stress
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 10 Mar 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
Who may be able to join
- Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
- Between 18-80 years
Who cannot join
- Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
- Patients who have had myocardial infarction within the past month
- Recurrent cardiovascular surgery
- Off-pump coronary artery bypass surgery (OPCAB)
- Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
- Patients with chronic renal failure, liver disease, active infection
- Patients older than 80 years and smaller than 18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, 251/A 46040
About this study
Official title: The Effect of PEEP and Tidal Volume on Thiol / Disulphide and Other Oxidative Stress Parameters in Cardio Pulmonary Bypass Surgery
Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have been reported to be directly related to this practice.Mechanisms explaining this condition have been described as being related to several events that occur during the cardiopulmonary bypass (CPBS), where blood is exposed to non-physiological surfaces, surgical trauma, ischemia-reperfusion, and changes in body temperature.In addition, CPB induces atelectasis and affects the structure of the bronchoalveolar tree.Prolongation of atelectasis may facilitate proinflammatory cytokine production by macrophages.One of the most damaging consequences of all these events is the formation of reactive oxygen species (ROS) and radicals originating from various cellular and enzymatic sources such as myocardial cells, activated neutrophils.ROS has toxic effects on cellular structures including lipids, proteins and nucleic acids.Oxidative reaction damages cellular function and may increase perioperative or postoperative complications after CPBS.Total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) reflect the redox balance between oxidation and antioxidation.TAS measurement is an indication of the activity of all antioxidants and TOS is an indicator of ROS.OSI is a measure of the ratio of TOS to TAS and the level of Oxidative Stress (OS).The contribution of various mechanisms to oxidant-antioxidant balance during on-pump coronary artery bypass grafting (ONCABG) has not yet been fully evaluated. The investigator's aim in this study is to investigate the effect of lung protective mechanism (Tidal Volum, PEEP) on oxidative stress parameters such as TAS, TOS, Thiol / Disulphide, Catalase, Glutathione Peroxidase, MDA (Melanil Dialdehyde) in cardio pulmonary bypass surgery
Read the detailed description
The study will be performed on patients who accept cardiopulmonary by-pass surgery, the conscious openness to participate in the study.Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases, drugs used, surgery, intervention, anesthetic agents used in induction and dyspepsia, peroperative supportive treatments, left ventricular ejection fraction, post operative blood and TDP amount CPB (cardiopulmonary bypass) time (min), Cross clamp time (min), cardioplegia amount and type, analgesic name and dose made, duration of operation, name of postoperative and perioperative support treatments , perioperative and post operative intake and urine output,postoperative extubation time, intensive care day of hospitalization, day of hospitalization will be recorded.The study was planned in 3 groups.Group 1 mechanical ventilator closed group (mechanical ventilator off) FiO2; 50%, Flow: 2 L / min. 2 Group Tidal Volume 3-4ml / kg (TV), FIO2 50%, Flow: 2L / min, Frequency; 10-12 applied group. 3. Group Tidal Volume 3-4 ml / kg, PEEP: 5 cm H2O pressure, FIO2 50%, Flow: 2 L / min, Frequency:Planned to be the 10-12 applied group.Pre-operative, operative (After the cross clamp is removed) and postoperative (postoperative 24th hour) blood will be collected from patients participating in the study.Thiol / Disulphide, MDA, TAS, TOS, Catalase and Glutathione Peroxidase will be studied. All patients should be premedicated with 0.1 mg / kg midazolam.Fentanyl (5-8 μg / kg), and rocuronium (0.5 mg / kg) will be used for induction of anesthesia. During anesthesia, 2% sevoflurane will be used.Arterial cannula to be inserted.Central venous catheter and urinary catheter will be placed. 3 - 5 mg / heparin and cardioplegia will be applied.The active clotting time (ACT) will be kept above 400.Heparin 1: to be neutralized with 1.3% of the Protamine.In the postoperative period, all patients will be transferred to the intensive care unit.
- Conditions
- Cardiac Surgery, Oxidative Stress
- Keywords
- peep, tidal volume, cardiopulmonary bypass, oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 1.Mechanical ventilator closed group (Mechanical ventilator off) | |
| Group 2 | 1. Tidal Voltage 3-4ml / kg (TV), 2. FIO2 50%, Flow: 2L / min, 3. Frequency; 10-12 applied group. | |
| Group 3 | 1. PEEP: 5 cm H2O basınç, 1. Tidal Voltage 3-4ml / kg (TV), 2. FIO2 50%, Flow: 2L / min, 3. Frequency; 10-12 applied group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers
To evaluate the impact on the circulating levels of Catalase ü/ml,Glutathione Peroxidase ü/ml, Malondialdehyde nmol/ ml, Thiol Disulfide,TAS, TOS
Measured: Change from baseline before operation (preoperative),peroperative,24 hours after surgery,
Secondary outcomes (2)
supportive care
Dopamine, Dobutamine,Gliserol Trinitrat, Adrenalin, Noradrenaline levels
Measured: used during surgery and during the first 24 hours after surgery
blood and fresh frozen plasma (FFP)
blood and fresh frozen plasma (FFP) quantities
Measured: used during surgery and during the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion1 Mar 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- yavuz orak, md, Principal investigator, Kahramanmaraş Sutcu Imam University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601364
- Sponsor's protocol ID
- 2018/10-12
- Status last verified
- Sep 2019
- First submitted
- 17 Jul 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PEEP and Tidal Volume on Thiol / Disulphide and Other Oxidative Stress Parameters in Cardio Pulmonary Bypass Surgery
- ClinicalTrials.gov ID
- NCT03601364
- Acronym / sponsor ID
- 2018/10-12
- Conditions
- Cardiac Surgery, Oxidative Stress
- Keywords
- peep, tidal volume, cardiopulmonary bypass, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 26 Jul 2018 (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.
Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have been reported to be directly related to this practice.Mechanisms explaining this condition have been described as being related to several events that occur during the cardiopulmonary bypass (CPBS), where blood is exposed to non-physiological surfaces, surgical trauma, ischemia-reperfusion, and changes in body temperature.In addition, CPB induces atelectasis and affects the structure of the bronchoalveolar tree.Prolongation of atelectasis may facilitate proinflammatory cytokine production by macrophages.One of the most damaging consequences of all these events is the formation of reactive oxygen species (ROS) and radicals originating from various cellular and enzymatic sources such as myocardial cells, activated neutrophils.ROS has toxic effects on cellular structures including lipids, proteins and nucleic acids.Oxidative reaction damages cellular function and may increase perioperative or postoperative complications after CPBS.Total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress index (OSI) reflect the redox balance between oxidation and antioxidation.TAS measurement is an indication of the activity of all antioxidants and TOS is an indicator of ROS.OSI is a measure of the ratio of TOS to TAS and the level of Oxidative Stress (OS).The contribution of various mechanisms to oxidant-antioxidant balance during on-pump coronary artery bypass grafting (ONCABG) has not yet been fully evaluated. The investigator's aim in this study is to investigate the effect of lung protective mechanism (Tidal Volum, PEEP) on oxidative stress parameters such as TAS, TOS, Thiol / Disulphide, Catalase, Glutathione Peroxidase, MDA (Melanil Dialdehyde) in cardio pulmonary bypass surgery
Detailed description
The study will be performed on patients who accept cardiopulmonary by-pass surgery, the conscious openness to participate in the study.Age, sex, body mass index (BMI), smoking habits, diagnosis, additional diseases, drugs used, surgery, intervention, anesthetic agents used in induction and dyspepsia, peroperative supportive treatments, left ventricular ejection fraction, post operative blood and TDP amount CPB (cardiopulmonary bypass) time (min), Cross clamp time (min), cardioplegia amount and type, analgesic name and dose made, duration of operation, name of postoperative and perioperative support treatments , perioperative and post operative intake and urine output,postoperative extubation time, intensive care day of hospitalization, day of hospitalization will be recorded.The study was planned in 3 groups.Group 1 mechanical ventilator closed group (mechanical ventilator off) FiO2; 50%, Flow: 2 L / min. 2 Group Tidal Volume 3-4ml / kg (TV), FIO2 50%, Flow: 2L / min, Frequency; 10-12 applied group. 3. Group Tidal Volume 3-4 ml / kg, PEEP: 5 cm H2O pressure, FIO2 50%, Flow: 2 L / min, Frequency:Planned to be the 10-12 applied group.Pre-operative, operative (After the cross clamp is removed) and postoperative (postoperative 24th hour) blood will be collected from patients participating in the study.Thiol / Disulphide, MDA, TAS, TOS, Catalase and Glutathione Peroxidase will be studied. All patients should be premedicated with 0.1 mg / kg midazolam.Fentanyl (5-8 μg / kg), and rocuronium (0.5 mg / kg) will be used for induction of anesthesia. During anesthesia, 2% sevoflurane will be used.Arterial cannula to be inserted.Central venous catheter and urinary catheter will be placed. 3 - 5 mg / heparin and cardioplegia will be applied.The active clotting time (ACT) will be kept above 400.Heparin 1: to be neutralized with 1.3% of the Protamine.In the postoperative period, all patients will be transferred to the intensive care unit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –1.Mechanical ventilator closed group (Mechanical ventilator off) |
| Group 2 | – | –1. Tidal Voltage 3-4ml / kg (TV), 2. FIO2 50%, Flow: 2L / min, 3. Frequency; 10-12 applied group. |
| Group 3 | – | –1. PEEP: 5 cm H2O basınç, 1. Tidal Voltage 3-4ml / kg (TV), 2. FIO2 50%, Flow: 2L / min, 3. Frequency; 10-12 applied group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
Key inclusion criteria (2 listed)
- Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
- Between 18-80 years
Key exclusion criteria (7 listed)
- Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
- Patients who have had myocardial infarction within the past month
- Recurrent cardiovascular surgery
- Off-pump coronary artery bypass surgery (OPCAB)
- Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxidative stress markers
Time frame: Change from baseline before operation (preoperative),peroperative,24 hours after surgery,
To evaluate the impact on the circulating levels of Catalase ü/ml,Glutathione Peroxidase ü/ml, Malondialdehyde nmol/ ml, Thiol Disulfide,TAS, TOS
2 secondary outcomes
supportive care
Time frame: used during surgery and during the first 24 hours after surgery
blood and fresh frozen plasma (FFP)
Time frame: used during surgery and during the first 24 hours 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 24 Sep 2019.
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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.
yavuz orak, md principal investigator
Kahramanmaraş Sutcu Imam University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Oxidative Stress, run by Kahramanmaras Sutcu Imam University 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 2 inclusion and 7 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 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 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?
Oxidative stress markers (time frame: Change from baseline before operation (preoperative),peroperative,24 hours after 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 24 Sep 2019.