Clinical trial NCT06001294: 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.
Official title: The Value of Serum ELABELA in Early Diagnosis of Sepsis-Associated Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Septic Shock
Acute Kidney Injury
Keywords: sepsis associated acute kidney injury
ELABELA
Lead sponsor: Huai'an No.1 People's Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis admitted to the ICU.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The value of ELABELA
timeFrame: 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
Secondary outcomes:
measure: 7-day survival rate
timeFrame: 7-day
Other outcomes:
Locations:
city: Huaian
country: China
facility: Department of Critical Care Medicine, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Huai'an No.1 People's Hospital
name: Xiangcheng Zhang
role: STUDY_DIRECTOR
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