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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04420897
Other study ID # The effect of Pa02 in KT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date December 1, 2020

Study information

Verified date December 2020
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We evaluated the prognostic role of the intraoperative arterial oxygen partial pressures (PaO2) on postoperative patient and graft survival in living donor kidney transplantations.


Description:

Undoubtedly, one of the most important elements of life on earth is oxygen. Aerobic organisms adapted to the 20.8% oxygen ratio in the atmosphere have survived even lower than this concentration by developing various defense mechanisms. The real question is whether high levels of oxygen in the blood, which are administered iatrogenically, leads to tissue destruction. 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.


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date December 1, 2020
Est. primary completion date November 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients who had living donor kidney transplantation between January 2014 and June 2019 at Akdeniz University Faculty of Medicine Organ Transplant Center. Exclusion Criteria: - Patients with missing data - Patients with a history of chronic heart failure or chronic respiratory disease (bronchial asthma, COPD). - Presence of cadaveric donor kidney transplantation

Study Design


Intervention

Procedure:
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.

Locations

Country Name City State
Turkey Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation Antalya

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of arterial blood gases with normoxia Approximately 1000 patients enrolled have living donor renal transplantation. After separation by study limitation of the accepted groups according to the PaO2 levels, graft functions and the patient's prognosis will be evaluated by enrolled data gained during the postoperative first month. Postoperative first following month
Primary Assessment of arterial blood gases with Moderate hyperoxemia Approximately 1000 patients enrolled have living donor renal transplantation. After separation by study limitation of the accepted groups according to the PaO2 levels, graft functions and the patient's prognosis will be evaluated by enrolled data gained during the postoperative first month. Postoperative first following month
Primary Assessment of arterial blood gases with Severe hyperoxemia Approximately 1000 patients enrolled have living donor renal transplantation. After separation by study limitation of the accepted groups according to the PaO2 levels, graft functions and the patient's prognosis will be evaluated by enrolled data gained during the postoperative first month. Postoperative first following month
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