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临床试验/NCT05458063
NCT05458063已完成不适用

The Effectiveness of the Urine Mitochondrial Deoxyribonucleic Acid and, Serum Beta 2 Microglobulin as a Biomarker of Renal Function Impairment in Critically Ill Surgical Patients

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2022年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
试验地点
1
主要终点
Acute kidney injury recovery (dichotomous)

研究概览

简要总结

  1. Research background

  2. Research hypothesis The development of acute kidney injury (AKI) can be predicted using urine mitochondrial deoxyribonucleic acid (UmtDNA), serum and urine beta-2 microglobulin (β2-MG) in critically ill surgical patients

  3. Basis of research hypothesis

i. Correlation between mitochondria and renal function (Results of previous studies)

  • Mitochondria are involved in development and recovery of diabetic nephropathy.
  • UmtDNA can be used as early marker to detect the development of AKI

※ Mitochondria

  • As an organelle located within the cell, it is an organ that produces energy through adenosine triphosphate (ATP) through cellular oxidative phosphorylation.
  • The kidney has the second most mitochondria after the heart.

II. Correlation between elevation of β2-MG and renal function

  • Circulating β2-MG infiltrates the glomerulus and is reabsorbed and metabolized in the proximal tubule of the kidney. Therefore, it increases in the blood due to a decrease in metabolism when renal function is abnormal.

※ Beta 2-microglobulin

  • As the light chain of the class I major histocompatibility antigen, it is a protein distributed in nucleated cells (especially lymphocytes and monocytes) in the body.

III. Mechanism of acute kidney injury in critically ill surgical patients

  • Blood flow to the kidneys is reduced due to decreased cardiac output, vasoconstriction due to systemic inflammatory response, hemodynamic changes, and decreased body fluid. This leads to renal tubular injury along with ischemic reperfusion injury.
  • Renal tubular injury increases the permeability of the transition pore that connects the outer and inner mitochondrial membranes, resulting in mitochondrial structural damage and oxidative injury. It causes a decrease of ATP in kidney cells and induces apoptosis of kidney cells.
  • Urine mtDNA, a product of this kidney injury, could be used as a biomarker to predict impairment of renal function in critically ill surgical patients.
  • Serum β2-MG maybe increase due to a decrease of metabolism of β2-MG in AKI.

详细描述

  1. Research objective

  2. Demonstrate of the association between urine mitochondrial deoxyribonucleic acid copy number (UmtDNAcn), beta 2-microglobulin (β2-MG) and acute kidney injury in critically ill surgical patients

  3. Demonstrate of the effectiveness of UmtDNAcn and β2-MG as a biomarker to predict AKI development and recovery

  4. Contents of the research project.

  5. Analysis of correlation between UmtDNAcn, β2-MG and development of AKI

  • Verifying the correlation between UmtDNAcn and blood β2-MG measured at the initial presentation and patients diagnosed AKI according to the Acute Kidney Injury Network (AKIN) criteria.
  1. Analysis of correlation between UmtDNAcn, β2-MG and recovery of AKI

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All surgical patients who planned to admit to surgical and trauma intensive care unit in emergency room

排除标准

  • Age ≤18 years
  • Pregnancy in women
  • Chronic kidney disease history
  • Death at initial presentation of the case

结局指标

主要结局

Acute kidney injury recovery (dichotomous)

时间窗: Within 30 days after ICU admission

the case when the AKI stage according to the AKIN criteria on the 7th day of AKI onset was reduced from AKI stage measured at the beginning of the AKI onset

Acute kidney injury (dichotomous)

时间窗: Within 30 days after ICU admission

Acute kidney injury according to Acute Kidney Injury Network (AKIN) criteria

次要结局

  • Mortality (dichotomous)(Within 30 days after ICU admission)
  • Hospital length of stay (continuous)(From date of the admission until the date of first discharge from the hospital, assessed up to 60 days)
  • Intensive care unit (ICU) stay (continuous)(From date of ICU admission (in cases of ICU admission at the initial presentation) until the date of first discharge from ICU, assessed up to 60 days)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwangmin Kim

Clinical assistant professor

Wonju Severance Christian Hospital

研究点 (1)

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