The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
- Conditions
- End-stage Renal Disease
- Registration Number
- NCT04575077
- Lead Sponsor
- Yonsei University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- The patients who plan to undergo kidney transplantation
- ASA III-IV
- adult over 19 years old
- emergent case
- heart disease
- arrhythmia
- BMI >30kg/m2
- allergy to some drugs
- if other co-operation is planned
- foreigner
- Illiteracy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method acute kidney injury 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.)
- Secondary Outcome Measures
Name Time Method 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 Laboratory test(reticulocyte count, Hb, plasma hepcidin, iron profiles (serum iron, serum ferritin, total iron-binding capacity, transferrin, transferrin saturation), coagulation profiles (PT, PTT), 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), routine urinary analysis
the number of participants with wound infection 6 months after surgery major adverse cardiac event 6 months after surgery
Trial Locations
- Locations (1)
Yonsei Severance Hospital
🇰🇷Seoul, Korea, Republic of