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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04575077
Other study ID # 4-2020-0748
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 16, 2020
Est. completion date August 2022

Study information

Verified date September 2020
Source Yonsei University
Contact Bon-Nyeo Koo, PhD
Phone 82-2-2228-2422
Email koobn@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 2022
Est. primary completion date February 2022
Accepts healthy volunteers
Gender All
Age group 19 Years to 99 Years
Eligibility Inclusion Criteria:

1. The patients who plan to undergo kidney transplantation

2. ASA III-IV

3. adult over 19 years old

Exclusion Criteria:

1. emergent case

2. heart disease

3. arrhythmia

4. BMI >30kg/m2

5. allergy to some drugs

6. if other co-operation is planned

7. foreigner

8. Illiteracy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Yonsei Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary acute kidney injury 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.) 6 months
Secondary numbers of participants with abnormal laboratory values 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 1) 1 month before the surgery, 2) Postoperative day(POD) 1, 3) 2 weeks after the surgery
Secondary the number of participants with wound infection 6 months after surgery
Secondary major adverse cardiac event 6 months after surgery
Secondary the number of participants who hospitalize again 6 months after surgery
Secondary mortality 6 months after surgery
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