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. (ELABELA（ELA）)
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| ClinicalTrials.gov Identifier: NCT06001294 |
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Recruitment Status :
Recruiting
First Posted : August 21, 2023
Last Update Posted : August 22, 2023
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Sponsor:
Xiangcheng Zhang
Information provided by (Responsible Party):
Xiangcheng Zhang, Huai'an No.1 People's Hospital
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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 |
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| Sepsis Septic Shock Acute Kidney Injury |
| Study Type : | Observational |
| Estimated 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 : | July 3, 2022 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- The value of ELABELA [ Time Frame: 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 :
- 7-day survival rate [ Time Frame: 7-day ]The significance of serum ELABELA in evaluating the short-term prognosis of sepsis-associated renal injury.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with sepsis admitted to the ICU.
Criteria
Inclusion Criteria:
Patients with sepsis admitted to the ICU.
Exclusion Criteria:
- Under 18 years old;
- History of chronic kidney disease;
- Recipients of organ transplantation within the past year;
- Patients or their families could not give informed consent.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001294
Contacts
| Contact: Xiangcheng Zhang | +8615896169171 | zhxc0318@163.com | |
| Contact: Tiantian Wang | +8618829715580 | wtttxjy@stu.njmu.edu.cn |
Locations
| China, Jiangsu | |
| Department of Critical Care Medicine, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University | Recruiting |
| Huaian, Jiangsu, China, 223001 | |
| Contact: Xiangcheng Zhang +8615896169171 zhxc0318@163.com | |
| Contact: Tiantian Wang +8618829715580 wtttxjy@stu.njmu.edu.cn | |
| Principal Investigator: Xiangcheng Zhang | |
Sponsors and Collaborators
Xiangcheng Zhang
Investigators
| Study Director: | Xiangcheng Zhang | Huai'an No.1 People's Hospital |
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: | August 21, 2023 Key Record Dates |
| Last Update Posted: | August 22, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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, Huai'an No.1 People's Hospital:
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sepsis associated acute kidney injury ELABELA |
Additional relevant MeSH terms:
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Sepsis Toxemia Shock, Septic Acute Kidney Injury Wounds and Injuries Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Shock Renal Insufficiency Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |