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The Effects of Peep and Tidal Volume on Oxidative Stress in Cardiopulmonary Bypass Surgery

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ClinicalTrials.gov Identifier: NCT03601364
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yavuz Orak, Kahramanmaras Sutcu Imam University

Brief 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 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

Condition or disease
Cardiac Surgery Oxidative Stress

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of PEEP and Tidal Volume on Thiol / Disulphide and Other Oxidative Stress Parameters in Cardio Pulmonary Bypass Surgery
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 10, 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. supportive care [ Time Frame: used during surgery and during the first 24 hours after surgery ]
    Dopamine, Dobutamine,Gliserol Trinitrat, Adrenalin, Noradrenaline levels

  2. blood and fresh frozen plasma (FFP) [ Time Frame: used during surgery and during the first 24 hours after surgery ]
    blood and fresh frozen plasma (FFP) quantities



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who will be cardiopulmonary by-pass surgery and volunteer to participate in the study will be included in the study.
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601364


Locations
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Turkey
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, Turkey, 251/A 46040
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Principal Investigator: yavuz orak, md Kahramanmaraş Sutcu Imam University Faculty of Medicine

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Responsible Party: Yavuz Orak, Assistant Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT03601364     History of Changes
Other Study ID Numbers: 2018/10-12
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yavuz Orak, Kahramanmaras Sutcu Imam University:
peep, tidal volume, cardiopulmonary bypass, oxidative stress