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.

NCT ID: NCT06001294

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-03

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Sepsis Septic Shock Acute Kidney Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiangcheng Zhang

OTHER

Sponsor Role lead

Responsible Party

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Xiangcheng Zhang

Director of Intensive Care Medicine Department, Huai'an First People's Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiangcheng Zhang

Role: STUDY_DIRECTOR

Huai'an No.1 People's Hospital

Locations

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Department of Critical Care Medicine, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Huaian, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangcheng Zhang

Role: CONTACT

+8615896169171

Tiantian Wang

Role: CONTACT

+8618829715580

Facility Contacts

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Xiangcheng Zhang

Role: primary

+8615896169171

Tiantian Wang

Role: backup

+8618829715580

References

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Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.

Reference Type BACKGROUND
PMID: 25018918 (View on PubMed)

Ronco C, Bellomo R, Kellum JA. Acute kidney injury. Lancet. 2019 Nov 23;394(10212):1949-1964. doi: 10.1016/S0140-6736(19)32563-2.

Reference Type BACKGROUND
PMID: 31777389 (View on PubMed)

Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.

Reference Type BACKGROUND
PMID: 26162677 (View on PubMed)

Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.

Reference Type BACKGROUND
PMID: 19066848 (View on PubMed)

Bagshaw SM, Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten HM, Ronco C, Kellum JA; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Septic acute kidney injury in critically ill patients: clinical characteristics and outcomes. Clin J Am Soc Nephrol. 2007 May;2(3):431-9. doi: 10.2215/CJN.03681106. Epub 2007 Mar 21.

Reference Type BACKGROUND
PMID: 17699448 (View on PubMed)

Wen Y, Parikh CR. Current concepts and advances in biomarkers of acute kidney injury. Crit Rev Clin Lab Sci. 2021 Aug;58(5):354-368. doi: 10.1080/10408363.2021.1879000. Epub 2021 Feb 8.

Reference Type BACKGROUND
PMID: 33556265 (View on PubMed)

Chng SC, Ho L, Tian J, Reversade B. ELABELA: a hormone essential for heart development signals via the apelin receptor. Dev Cell. 2013 Dec 23;27(6):672-80. doi: 10.1016/j.devcel.2013.11.002. Epub 2013 Dec 5.

Reference Type BACKGROUND
PMID: 24316148 (View on PubMed)

Chen H, Wang L, Wang W, Cheng C, Zhang Y, Zhou Y, Wang C, Miao X, Wang J, Wang C, Li J, Zheng L, Huang K. ELABELA and an ELABELA Fragment Protect against AKI. J Am Soc Nephrol. 2017 Sep;28(9):2694-2707. doi: 10.1681/ASN.2016111210. Epub 2017 Jun 5.

Reference Type BACKGROUND
PMID: 28583915 (View on PubMed)

Other Identifiers

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Huaian1H

Identifier Type: -

Identifier Source: org_study_id

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