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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cancer, Adult
• Intervention / Treatment: Behavioral: Risk-stratified active nursing intervention group; Behavioral: Standard care (usual post-interventional nursing care)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yongjian wang; Phone Number: +8617831102606; Email: 1251210544@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risk-stratified active nursing intervention group	Behavioral: 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, postoperative day 1, postoperative day 2, postoperative day 3, and after hospital discharge. Intervention strategies are designed around the six core constructs of the Health Belief Model, including perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy. Specific measures encompass medication management, fluid therapy, renal function monitoring, patient and family education, behavioral support, and follow-up management
Active Comparator: Standard care (control) group	Behavioral: Standard care (usual post-interventional nursing care); Standard care (usual post-interventional nursing care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative acute kidney injury incidence	The primary outcome was the occurrence of postoperative acute kidney injury (AKI). AKI was assessed within the first 7 days following interventional therapy and defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines as the presence of any of the following: (1) an increase in serum creatinine of ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours; (2) an increase in serum creatinine to ≥1.5 times the baseline level, known or presumed to have occurred within the prior 7 days; or (3) a urine output of <0.5 mL/kg/h for at least 6 hours.	AKI was assessed within the first 7 days following interventional therapy

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: bc20262331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared because the dataset contains sensitive clinical information that may pose a risk of participant re-identification despite de-identification procedures. In addition, data sharing is restricted by institutional ethics requirements and the informed consent provided by participants. Requests for access to de-identified data may be considered on a reasonable basis and subject to approval by the corresponding institution and ethics committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No