The Effect of Intraoperative Arterial Oxygen Pressures on Early Post-Operative Patient and Graft Survival in Living Donor Kidney Transplantation
NCT ID: NCT04420897
Last Updated: 2020-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
247 participants
OBSERVATIONAL
2020-05-01
2020-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Reactive Oxygen Species (ROS), which is a result of hyperoxia and may be useful even at low levels, may cause tissue loss due to oxidative stress, also called oxygen-free radicals. ROS, whose toxicity is very destructive with its accumulation, may cause damage to macromolecular structures such as lipids, protein, mitochondrial and nuclear DNA. On the organs of the exposed oxidative stress; For lung, asthma, chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), cardiovascular system, ischemic heart disease (IHD), hypertension, shock, heart failure, while kidney failure and glomerulonephritis can cause unwanted complications.
The kidneys get for circulation, only 20% of the cardiac output. Since the arterial and venous (AV) structures in the kidneys are anatomically parallel to each other, the oxygen concentration in the renal vein may be relatively higher than the efferent arteriole and cortex because of the oxygen shunt. Thanks to this mechanism, in clinical situations where partial oxygen pressure (Pa02) is high, the oxygen concentration presented to the kidney tissues remains within a certain limit. In fact, AV shunt protects kidney tissue with a structural antioxidant mechanism. Thus, the increase in renal blood flow (RBF) will cause an increase in AV oxygen shunt in parallel, the blood coming to the kidneys participates in the systemic circulation without entering the renal microcirculation. It has been suggested that shunt occurs to protect from hyperoxia at the tissue level by decreasing blood volume in the kidneys. Oxidative stress, which is inevitable as a result, will increase tissue hypoxia paradoxically by increasing the oxygen consumption of the kidneys. It is stated that uremic toxin, especially indoxyl sulfate (IS) accumulation is the cause of the mentioned table. Apart from IS, phenyl sulfate and ρ-cresy sulfate make tubular cells susceptible by reducing glutathione levels. Thus, increased renal hypoxia, renal oxidative stress will result in renal inflammation and fibrosis.
According to recent studies, the antioxidant defense mechanism has been shown not only to be limited to AV shunt. But also the dynamic regulation of intrarenal oxygenation in RBF changes. However, mechanisms developed to prevent hyperoxia have made kidney tissue sensitive to hypoxia. The increase in AV oxygen shunt causes an increase in tissue hypoxia.
Although endogenous antioxidant mechanisms play a major role against free radicals, the postoperative effects of iatrogenic hyperoxia on transplanted kidney grafts and patient survival remain a subject to be investigated. That's why we aim to understand the impact of iatrogenic hyperoxia during the living donor kidney transplantation operations by retrospective data analyzing.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normoxy: PaO2 = 80-120 mm Hg
Data collection explained below: Arterial blood samples from all groups shall be taken after induction, 5 minutes after graft perfusion, and end of surgery in the intraoperative period, in the operating room. The duration of the intensive care unit (ICU), the duration of mechanical ventilation in intensive care, Whether or not to re-intubate, hospital stay, intraoperative and postoperative laboratory data, immunosuppression regimen, postoperative complications (surgical site infection, ischemic vascular conditions, complications from respiratory) and interventions will be included for the study analysis. The survival of the patients will be enrolled, and the relationship between the obtained data and survival will be investigated. For early-stage graft survival, postoperatively; Data such as renal replacement therapy, the total amount of urine levels, creatinine values, presence of delayed graft function will be recorded.
Arterial blood gas samples
Blood gases taken during the operation will be analyzed retrospectively. Whether these results have an effect on graft survival will be examined by reaching their records in the postoperative period.
Moderate hyperoxemia: PaO2 =120-200 mm Hg
Data collection explained below: Arterial blood samples from all groups shall be taken after induction, 5 minutes after graft perfusion, and end of surgery in the intraoperative period, in the operating room. The duration of the intensive care unit (ICU), the duration of mechanical ventilation in intensive care, Whether or not to re-intubate, hospital stay, intraoperative and postoperative laboratory data, immunosuppression regimen, postoperative complications (surgical site infection, ischemic vascular conditions, complications from respiratory) and interventions will be included for the study analysis. The survival of the patients will be enrolled, and the relationship between the obtained data and survival will be investigated. For early-stage graft survival, postoperatively; Data such as renal replacement therapy, the total amount of urine levels, creatinine values, presence of delayed graft function will be recorded.
Arterial blood gas samples
Blood gases taken during the operation will be analyzed retrospectively. Whether these results have an effect on graft survival will be examined by reaching their records in the postoperative period.
Severe hyperoxemia: PaO2 >200 mm Hg
Data collection explained below: Arterial blood samples from all groups shall be taken after induction, 5 minutes after graft perfusion, and end of surgery in the intraoperative period, in the operating room. The duration of the intensive care unit (ICU), the duration of mechanical ventilation in intensive care, Whether or not to re-intubate, hospital stay, intraoperative and postoperative laboratory data, immunosuppression regimen, postoperative complications (surgical site infection, ischemic vascular conditions, complications from respiratory) and interventions will be included for the study analysis. The survival of the patients will be enrolled, and the relationship between the obtained data and survival will be investigated. For early-stage graft survival, postoperatively; Data such as renal replacement therapy, the total amount of urine levels, creatinine values, presence of delayed graft function will be recorded.
Arterial blood gas samples
Blood gases taken during the operation will be analyzed retrospectively. Whether these results have an effect on graft survival will be examined by reaching their records in the postoperative period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arterial blood gas samples
Blood gases taken during the operation will be analyzed retrospectively. Whether these results have an effect on graft survival will be examined by reaching their records in the postoperative period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients with a history of chronic heart failure or chronic respiratory disease (bronchial asthma, COPD).
* Presence of cadaveric donor kidney transplantation
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akdeniz University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bora Dinc
Assistant Professor Department of Anesthesiology and Reanimation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bora Di̇nc, MD, Assist. Prof.
Role: PRINCIPAL_INVESTIGATOR
Akdeniz University Medical Faculty
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation
Antalya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dinc B, Yilmaz VT, Aycan IO, Kisaoglu A, Dandin O, Aydinli B, Hadimioglu N, Ertug Z. Effect of post-perfusion hyperoxemia on early graft function in renal transplant recipients: a retrospective observational cohort study. Ir J Med Sci. 2021 Nov;190(4):1539-1545. doi: 10.1007/s11845-020-02499-7. Epub 2021 Jan 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
The effect of Pa02 in KT
Identifier Type: -
Identifier Source: org_study_id