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.

Recruiting

• Conditions: Acute Kidney Injury; Sepsis; Septic Shock

• Registration Number: NCT06001294
• Lead Sponsor: Xiangcheng Zhang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-03
• Status Verified: 2023-08
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-19
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
7-day survival rate	7-day	The significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury.

Trial Locations

Locations (1)

Department of Critical Care Medicine, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University; 🇨🇳 Huaian, Jiangsu, China