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

NCT03601364 | Completed

• 1 other identifier: 2018/10-12
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Surgery; Oxidative Stress

Keywords

peep, tidal volume, cardiopulmonary bypass, oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline before operation (preoperative),peroperative,24 hours after surgery,

Secondary Outcomes (2)

• supportive care

  used during surgery and during the first 24 hours after surgery

• blood and fresh frozen plasma (FFP)

  used during surgery and during the first 24 hours after surgery

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, Onikişubat, 251/A 46040, Turkey (Türkiye)

Location

Study Officials

• yavuz orak, md

  Kahramanmaraş Sutcu Imam University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 10, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

TU (1)