Risk Stratification and Proactive Nursing Intervention for Acute Kidney Injury Following Interventional Therapy in Patients With Liver Cancer
30 juni 2026 uppdaterad av: Tianjin Medical University Cancer Institute and Hospital
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
200
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: yongjian wang
- Telefonnummer: +8617831102606
- E-post: 1251210544@qq.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Aktiv komparator: Standard care (control) group
|
Standard care (usual post-interventional nursing care)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative acute kidney injury incidence
Tidsram: AKI was assessed within the first 7 days following interventional therapy
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 december 2028
Studieregistreringsdatum
Först inskickad
23 juni 2026
Först inskickad som uppfyllde QC-kriterierna
30 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Leversjukdomar
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Neoplasmer i levern
- Carcinom
- Karcinom, hepatocellulärt
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Vårdstandard
Andra studie-ID-nummer
- bc20262331
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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