Clinical Value of Plasma Humanin in Acute Kidney Injury

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06105229
Collaborator
(none)
60
1
22
2.7

Study Details

Study Description

Brief Summary

The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI Researchers will compare humanin concentration in healthy people to see if humanin can be a novel marker for predicting AKI

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute Kidney Injury (AKI) is a clinically critical condition manifested by a sharp decline in kidney function, with approximately 13.3 million people diagnosed with AKI each year in hospital worldwide and associated with 1.7 million deaths. According to global multi-center research data, the total incidence of AKI in hospital is as high as 21%, and the incidence of acute kidney injury in hospitalized patients in China is 0.99%~11.6%. AKI increases the risk of long-term chronic kidney disease (CKD) and end-stage renal disease (ESRD), and has a very high long-term mortality rate. The diagnosis of AKI is mainly based on blood creatinine or urine output, and the current KDIGO criteria are used, but blood 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. In our previous study, the investigators found that Humanin was elevated in plasma in a mouse model of AKI with sepsis.

    The goal of this observational study is to assess the clinical value of humanin in acute kidney injury. The main questions it aims to answer are:whether Humanin can be a novel marker for predicting AKI

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Clinical Value of Plasma Humanin in Acute Kidney Injury
    Actual Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Acute kidney injury

    Patients with AKI who meet KDIGO criteria

    Healthy controls

    Healthy people without other underlying medical conditions

    Outcome Measures

    Primary Outcome Measures

    1. Humanin concentration [one week]

      Highest measured value used

    2. Serum creatinine concentration [one week]

      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:
    Yes
    Inclusion Criteria:
    • Adult patients ≥ 18 years of age, male or female;

    • Patients with AKI: Patients with acute kidney injury who meet the definition of KDIGO guidelines;

    • Control group: from healthy physical examination population, physical examination blood routine, urine routine, liver function, kidney function, glycated hemoglobin and other indicators are normal;

    • The patient's baseline medical record data is complete, including liver and kidney function, urine protein level, blood creatinine value, etc;

    • Consent to enrollment and sign informed consent;

    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

    • Guangdong Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Li zhilian, Deputy Chief Physician, Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06105229
    Other Study ID Numbers:
    • NO.GDREC2020278H
    First Posted:
    Oct 27, 2023
    Last Update Posted:
    Oct 27, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 27, 2023