Risk Stratification and Proactive Nursing Intervention for Acute Kidney Injury Following Interventional Therapy in Patients With Liver Cancer

Обзор

This study focuses on the early identification and precision prevention of acute kidney injury (AKI) following interventional therapy in patients with liver cancer. A prospective, phased mixed-methods research design will be adopted. In the first phase, a prospective cohort study will be conducted to systematically collect clinical and nursing-related data. A Super Learner ensemble algorithm will be employed to develop and validate an AKI risk prediction model, enabling precise risk stratification of patients. In the second phase, a prospective randomized controlled trial will be implemented. Guided by the Health Belief Model (HBM), a risk-stratified proactive nursing intervention will be delivered, and its effectiveness will be compared with that of routine nursing care in reducing the incidence of AKI, improving adherence to hydration protocols, optimizing the management of nephrotoxic medications, and enhancing patients' self-management capabilities. By integrating intelligent risk prediction with proactive nursing intervention strategies, this study aims to establish a reproducible and scalable precision prevention and management model for AKI in liver cancer patients undergoing interventional therapy. The findings are expected to provide scientific evidence for early AKI warning and proactive nursing practice, thereby promoting the precision, intelligence, and standardization of oncologic interventional nursing care.

Вмешательства

• Поведенческое Risk-stratified active nursing intervention group
  The intervention employed in this study is a proactive nursing intervention package based on AKI risk stratification and the Health Belief Model (HBM). Prior to interventional therapy, participants are assessed using the AKI risk prediction model and categorized into low-, moderate-, and high-risk groups. Stratified and weighted interventions are then implemented according to the assigned risk level. The intervention is delivered at five critical time points: one day before the procedure, posto
• Поведенческое Standard care (usual post-interventional nursing care)
  Standard care (usual post-interventional nursing care)

Первичные конечные точки

• Postoperative acute kidney injury incidence [Срок оценки: AKI was assessed within the first 7 days following interventional therapy]

Критерии участия

Критерии включения

• Completed eligibility screening in Phase I of the study
• Completed AKI risk assessment using the established prediction model
• Classified by the model as at risk for AKI (moderate- or high-risk patients prioritized; low-risk patients included only for exploratory/observational analysis)
• Conscious and able to communicate effectively
• Able to understand and comply with nursing interventions
• Expected hospital stay of at least 3 days
• Available for postoperative follow-up
• Provided written informed consent jointly with a primary caregiver

Критерии исключения

• Development of AKI within 24 hours after interventional therapy according to KDIGO criteria
• Severe psychiatric disorders, cognitive impairment, or communication barriers preventing participation in HBM-based assessment or intervention
• Requirement for postoperative ICU admission and continuous life-support therapy
• Mandatory use of nephrotoxic medications that cannot be discontinued, substituted, or adjusted during the study period
• Participation in other clinical intervention studies that may affect renal function or nursing outcomes

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Ostermann M, Lumlertgul N, Jeong R, See E, Joannidis M, James M. Acute kidney injury. Lancet. 2025 Jan 18;405(10474):241-256. doi: 10.1016/S0140-6736(24)02385-7. PMID 39826969
• Cerda J, Kashani K, Ostermann M, Basu RK, Bell S, Cantaluppi V, Chakaravarthi R, Costa JM, Claure-Del Granado R, Macedo E, Rhee H, Srisawat N, Wu VC, Yang L, Mehta RL. The global epidemiology of acute kidney injury: challenges and opportunities. Nat Rev Nephrol. 2026 Mar;22(3):179-198. doi: 10.1038/s41581-025-01030-4. Epub 2025 Dec 5. PMID 41350436
• Li Y, Wang J. Contrast-induced acute kidney injury: a review of definition, pathogenesis, risk factors, prevention and treatment. BMC Nephrol. 2024 Apr 22;25(1):140. doi: 10.1186/s12882-024-03570-6. PMID 38649939
• Fu C, Chen H, Chen Y, et al. Transarterial intervention therapy combined with systemic therapy for HCC: a review of recent five-year articles [J]. Hepatoma Research, 2024, 10: 42.

Идентификаторы

NCT: NCT07681817 · bc20262331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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