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临床试验/NCT04575077
NCT04575077Unknown不适用

The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation

Yonsei University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
acute kidney injury

研究概览

简要总结

High hepcidin concentrations indicate that iron is blocked from secretion from the reservoir. Hepcidin may be useful in prediction functional iron utilization in renal failure patients. Hepcidin is also associated with chronic renal failure and residual renal function in dialysis patients. Recent studies have shown that hepcidin is a potential marker of impaired renal function in a rat model of chronic nephropathy.

The purpose of this study was to investigate the relationship between preoperative hepcidin levels and the incidence of success rate of kidney transplantation in patients with end-stage renal failure undergoing kidney transplantation surgery. The study is a prospective single-group observational study that analyzes hepcidin as a biomarker.

详细描述

POD-1 : Researchers will meet patients scheduled for surgery and explain the study. (enroll) the operation date : The patient will sign the consent form. Researchers will collect the blood sample from the patient for testing hepcidin during the operation and record laboratory data performed before surgery POD 1: laboratory test discharge date : laboratory test 6 months after surgery ; Researchers will determine the graft failure of the patient.

* laboratory test ; reticulocyte count, Hb, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles (PT, PTT), routine urinary analysis, and chemical profiles (aspartate aminotransferase (AST)/alanine aminotransaminase (ALT), serum creatinine, electrolytes, C-reactive protein (CRP), estimated glomerular filtration rate (GFR)), ESR, cystatin C, NGAL, pro BNP, troponin T and urinary analysis

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients who plan to undergo kidney transplantation
  • adult over 19 years old

排除标准

  • emergent case
  • heart disease
  • BMI >30kg/m2
  • allergy to some drugs
  • if other co-operation is planned

结局指标

主要结局

acute kidney injury

时间窗: 6 months

AKIN Criteria have only three stages of AKI (Stages I-III) which generally correspond to RIFLE stages R, I, and F. The AKIN group claims an advantage over the RIFLE criteria in that it has a lower threshold for defining an individual as Stage I AKI (only 0.3 mg/dL increase OR a 1.5X increase over baseline is required to meet this definition in AKIN; in RIFLE one requires a 1.5X increase over baseline. Both definitions can also be met by urine output criteria as well.)

次要结局

  • the number of participants who hospitalize again(6 months after surgery)
  • mortality(6 months after surgery)
  • numbers of participants with abnormal laboratory values(1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery)
  • the number of participants with wound infection(6 months after surgery)
  • major adverse cardiac event(6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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