ELABELA(ELA): We Collected Blood Samples From Septic Shock Patients and Measured ELABELA, Creatinine, and NGAL Levels. Survival After 7 Days Was Recorded and Analyzed to Evaluate the Potential of Serum ELABELA as an Early Diagnostic Marker for Sepsis-associated Acute Kidney Injury.

Sponsor
Xiangcheng Zhang (Other)
Overall Status
Recruiting
CT.gov ID
NCT06001294
Collaborator
(none)
70
1
17.9
3.9

Study Details

Study Description

Brief Summary

The investigators selected patients diagnosed with sepsis who were admitted to the Intensive Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as well as healthy individuals with normal kidney function during the same period, for the research. The investigators collected blood samples from patients with septic shock or sepsis at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis, and also collected blood samples from the healthy individuals. The blood samples were stored in gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay) were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The subjects were divided into three groups based on the KDIGO diagnostic criteria: sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control group. Finally, the data were analyzed to determine the early diagnostic value of ELA for S-AKI. Approximately 70 specimens were collected in total.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Value of Serum ELABELA in Early Diagnosis of Sepsis-Associated Acute Kidney Injury
    Actual Study Start Date :
    Jul 3, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The value of ELABELA [Venous blood samples were collected at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days and 7 days after the diagnosis of sepsis or septic shock]

      Significance of serum ELABELA in the early diagnosis of sepsis-associated renal injury.

    Secondary Outcome Measures

    1. 7-day survival rate [7-day]

      The significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Patients with sepsis admitted to the ICU.

    Exclusion Criteria:
    1. Under 18 years old;

    2. History of chronic kidney disease;

    3. Recipients of organ transplantation within the past year;

    4. Patients or their families could not give informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Critical Care Medicine, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University Huaian Jiangsu China 223001

    Sponsors and Collaborators

    • Xiangcheng Zhang

    Investigators

    • Study Director: Xiangcheng Zhang, Huai'an No.1 People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xiangcheng Zhang, Director of Intensive Care Medicine Department, Huai'an First People's Hospital, Huai'an No.1 People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06001294
    Other Study ID Numbers:
    • Huaian1H
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 22, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiangcheng Zhang, Director of Intensive Care Medicine Department, Huai'an First People's Hospital, Huai'an No.1 People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2023