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Humanin's Value for Early Diagnosis and Short-term Prognosis in Patients With AKI After Heart Transplantation

Sponsor
Li zhilian (Other)
Overall Status
Recruiting
CT.gov ID
NCT06125249
Collaborator
(none)
60
Enrollment
1
Location
23
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation. The main question it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation Researchers will compare the Humanin concentration in patients with AKI did not occur after heart transplantation to see if Humanin can be a novel marker for predicting AKI after heart transplantation

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Heart transplantation is an important means of treating end-stage heart disease, acute kidney injury is a common complication after heart transplantation, can lead to perioperative and early postoperative patient death, can also lead to the development of chronic kidney disease after heart transplantation, and even progress to ESRD, the literature reports that the incidence of acute kidney injury after heart transplantation is 14% ~ 76%, resulting in severe renal impairment and the proportion requiring dialysis treatment is 5% ~ 39%. The diagnosis of AKI is mainly based on serum creatinine or urine output, and KDIGO criteria are currently used, but it is known that serum creatinine is a very insensitive indicator,so in the past 20 years, scholars have been exploring biological markers that are more sensitive than blood creatinine and urine output. Humanin is a mitochondrial polypeptide containing 24 amino acids. It was first identified in Alzheimer's disease patients in 2001. Studies have shown that Humanin has a strong mitochondrial protective effect in neurodegenerative diseases, cardiovascular diseases, diabetes, male infertility, cancer and other diseases, and its mechanism may be related to anti-apoptosis, anti-inflammation, regulation of autophagy and maintenance of mitochondrial homeostasis, because Humanin can function through autocrine, paracrine or endocrine forms, so it can be detected in the blood. Studies have shown that Humanin expression in serum or plasma of patients with diabetes and coronary heart disease is declined. Our previous study found the concentration of Humanin in AKI patients was significantly higher than in the normal population.

    The goal of this observational study is to explore the value of Humanin for early diagnosis and short-term prognosis of AKI patients after heart transplantation.. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI after heart transplantation

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Humanin's Value for Early Diagnosis and Short-term Prognosis in Patients With AKI After Heart Transplantation
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with AKI after heart transplantation

    AKI occurs in patients after heart transplantation
    Patients did not develop AKI after heart transplantation

    Patients who do not develop AKI after heart transplantation

    Outcome Measures

    Primary Outcome Measures

    1. Humanin concentration [3 months]

      Highest measured value used

    2. Serum creatinine concentration [3 months]

      Meets KDIGO's definition of AKI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Guangdong Provincial People's Hospital performs heart transplantation；Adult patients ≥ 18 years of age, male or female；Basic renal function is normal before surgery；The patient's baseline medical records are complete, including basic heart diseases, comorbidities, hemoglobin, renal function, urine protein quantification, serum albumin, lactic acid, C-reactive protein, heart transplantation operation time, preoperative and postoperative medication and blood pressure, blood transfusion history, ICU length of stay, cardiac ultrasound (including LVEF), etc；

    Exclusion Criteria:

    Age< 18 years；Baseline data were missing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangdong Provincial People's Hospital Guangdong Guangzhou China 510000

    Sponsors and Collaborators

    • Li zhilian

    Investigators

    • Principal Investigator: zhilian PP li, doctor, Guangdong Provincial People's Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Li zhilian, Deputy Chief Physician, Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06125249
    Other Study ID Numbers:
    • KJ012019455
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Kidney Injury

    Study Results

    No Results Posted as of Nov 9, 2023