Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy

NCT ID: NCT07088874

Last Updated: 2025-09-08

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

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-02

Study Completion Date

2027-07-30

Brief Summary

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The incidence of acute kidney injury (AKI) after radical nephrectomy exceeds 40%. Currently, the KDIGO criteria are the recognized diagnostic standard for AKI. These criteria primarily use serum creatinine and urine output as key indicators, but both parameters have certain limitations, such as delayed response, insensitivity, and inaccuracy. This study aims to simultaneously monitor perioperative novel renal damaging, stressful, and functional biomarkers in patients undergoing radical nephrectomy, and to investigate their predictive value for AKI and postoperative 1-year chronic kidney disease (CKD).

Detailed Description

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Conditions

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Nephrectomy Acute Kidney Injury Biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AKI group/CKD group

1. patients diagnosed with AKI after radical nephrectomy.
2. patients diagnosed with the new onset/worsening of CKD after radical nephrectomy.

No interventions assigned to this group

non-AKI group/non-CKD group

1. patients without AKI after radical nephrectomy.
2. patients without new onset/worsening of CKD after radical nephrectomy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years;
* Scheduled to undergo unilateral radical nephrectomy.

Exclusion Criteria

* Solitary kidney;
* Preoperative diagnosis of chronic kidney disease stages G4 or G5 (GFR \<30 mL/min/1.73m²);
* Tumor invasion of the vena cava requiring thrombectomy;
* Other conditions deemed by the investigator as unsuitable for participation in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiongfang Wu

Peking University First Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiongfang Wu, MD

Role: CONTACT

8610 83572460

Facility Contacts

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Dong-Xin Wang, MD, PhD

Role: primary

8610 83572784

Qiongfang Wu, MD

Role: backup

8610 83572460

References

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Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

Reference Type BACKGROUND
PMID: 22890468 (View on PubMed)

Antonelli A, Allinovi M, Cocci A, Russo GI, Schiavina R, Rocco B, Giovannalberto P, Celia A, Galfano A, Varca V, Bozzini G, Ceruti C, Greco F, Verze P, Pastore AL, Porreca A, Minervini A; AGILE Group. The Predictive Role of Biomarkers for the Detection of Acute Kidney Injury After Partial or Radical Nephrectomy: A Systematic Review of the Literature. Eur Urol Focus. 2020 Mar 15;6(2):344-353. doi: 10.1016/j.euf.2018.09.020. Epub 2018 Oct 9.

Reference Type BACKGROUND
PMID: 30309817 (View on PubMed)

Rossiter A, La A, Koyner JL, Forni LG. New biomarkers in acute kidney injury. Crit Rev Clin Lab Sci. 2024 Jan;61(1):23-44. doi: 10.1080/10408363.2023.2242481. Epub 2023 Sep 5.

Reference Type BACKGROUND
PMID: 37668397 (View on PubMed)

Ostermann M, Zarbock A, Goldstein S, Kashani K, Macedo E, Murugan R, Bell M, Forni L, Guzzi L, Joannidis M, Kane-Gill SL, Legrand M, Mehta R, Murray PT, Pickkers P, Plebani M, Prowle J, Ricci Z, Rimmele T, Rosner M, Shaw AD, Kellum JA, Ronco C. Recommendations on Acute Kidney Injury Biomarkers From the Acute Disease Quality Initiative Consensus Conference: A Consensus Statement. JAMA Netw Open. 2020 Oct 1;3(10):e2019209. doi: 10.1001/jamanetworkopen.2020.19209.

Reference Type BACKGROUND
PMID: 33021646 (View on PubMed)

Gocze I, Jauch D, Gotz M, Kennedy P, Jung B, Zeman F, Gnewuch C, Graf BM, Gnann W, Banas B, Bein T, Schlitt HJ, Bergler T. Biomarker-guided Intervention to Prevent Acute Kidney Injury After Major Surgery: The Prospective Randomized BigpAK Study. Ann Surg. 2018 Jun;267(6):1013-1020. doi: 10.1097/SLA.0000000000002485.

Reference Type BACKGROUND
PMID: 28857811 (View on PubMed)

Kane-Gill SL, Peerapornratana S, Wong A, Murugan R, Groetzinger LM, Kim C, Smithburger PL, Then J, Kellum JA. Use of tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7 [TIMP2]*[IGFBP7] as an AKI risk screening tool to manage patients in the real-world setting. J Crit Care. 2020 Jun;57:97-101. doi: 10.1016/j.jcrc.2020.02.002. Epub 2020 Feb 4.

Reference Type BACKGROUND
PMID: 32086072 (View on PubMed)

Leem AY, Park MS, Park BH, Jung WJ, Chung KS, Kim SY, Kim EY, Jung JY, Kang YA, Kim YS, Kim SK, Chang J, Song JH. Value of Serum Cystatin C Measurement in the Diagnosis of Sepsis-Induced Kidney Injury and Prediction of Renal Function Recovery. Yonsei Med J. 2017 May;58(3):604-612. doi: 10.3349/ymj.2017.58.3.604.

Reference Type BACKGROUND
PMID: 28332367 (View on PubMed)

Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.

Reference Type BACKGROUND
PMID: 38490803 (View on PubMed)

Other Identifiers

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2025-067

Identifier Type: -

Identifier Source: org_study_id

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