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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.

The Value of Serum ELABELA in Early Diagnosis of Sepsis-Associated Acute Kidney Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06001294
Acronym
ELABELA(ELA)
Enrollment
70
Registered
2023-08-21
Start date
2022-07-03
Completion date
2023-12-31
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Sepsis, Septic Shock

Keywords

sepsis associated acute kidney injury, ELABELA

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.

Interventions

None listed

Sponsors

Xiangcheng Zhang
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The value of ELABELAVenous 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 shockSignificance of serum ELABELA in the early diagnosis of sepsis-associated renal injury.

Secondary

MeasureTime frameDescription
7-day survival rate7-dayThe significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury.

Countries

China

Contacts

Primary ContactXiangcheng Zhang
zhxc0318@163.com+8615896169171
Backup ContactTiantian Wang
wtttxjy@stu.njmu.edu.cn+8618829715580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026