Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy

Официальное название

Novel Biomarkers to Predict Acute Kidney Injury and Chronic Kidney Disease After Radical Nephrectomy: an Exploratory Prospective Cohort Study

Обзор

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).

Первичные конечные точки

• The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C and their combinations to predict postoperative AKI occurring within 7 days. [Срок оценки: Up to 7 days after surgery.]

Вторичные конечные точки (3)

• The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C and their combinations to predict new onset/worsening CKD occurring within 1 year after surgery. [Срок оценки: Up to 1 year after surgery]
• The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C combined with clinically important risk factors to predict postoperative AKI occurring within 7 days after surgery. [Срок оценки: Up to 7 days after surgery.]
• The postoperative urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C combined with clinically important risk factors to predict postoperative the new onset/worsening CKD occurring within 1 year after surgery. [Срок оценки: Up to 1 year after surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

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

Публикации

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• 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. PMID 37668397
• 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. 20 PMID 33021646
• 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. PMID 28857811
• 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. PMID 32086072
• 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. PMID 28332367
• 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. PMID 38490803

Идентификаторы

NCT: NCT07088874 · 2025-067

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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