Risk Stratification and Proactive Nursing Intervention for Acute Kidney Injury Following Interventional Therapy in Patients With Liver Cancer
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedFirst Posted
Study publicly available on registry
July 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 2, 2026
June 1, 2026
1.5 years
June 23, 2026
June 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Risk-stratified active nursing intervention group
EXPERIMENTALStandard care (control) group
ACTIVE COMPARATORInterventions
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
Standard care (usual post-interventional nursing care)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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: 39826969BACKGROUNDCerda 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: 41350436BACKGROUNDLi 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: 38649939BACKGROUNDFu 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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2026
First Posted
July 2, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.