Risk Stratification and Proactive Nursing Intervention for Acute Kidney Injury Following Interventional Therapy in Patients With Liver Cancer
30. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: yongjian wang
- Telefonnummer: +8617831102606
- E-post: 1251210544@qq.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative acute kidney injury incidence
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
30. juni 2026
Først lagt ut (Faktiske)
2. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Neoplasmer i leveren
- Karsinom
- Karsinom, hepatocellulært
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
Andre studie-ID-numre
- bc20262331
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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