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Development and Validation of a Prediction Model for AKI Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer

Development and Validation of a Prediction Model for Acute Kidney Injury Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer: a Multi-center Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06697613
Enrollment
150
Registered
2024-11-20
Start date
2016-01-01
Completion date
2024-08-31
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKI - Acute Kidney Injury, Ovarian Cancer

Brief summary

Ovarian cancer is the most lethal malignant tumor of the female reproductive system. Cytoreduction surgery(CRS) combined with chemotherapy is the primary method for treating ovarian cancer, and complete tumor resection is an important means to improve prognosis. It has been demonstrated that the use of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) following CRS can significantly improve the prognosis of some patients with ovarian cancer. However, HIPEC with cisplatin can lead to acute kidney injury (AKI), a serious complication that can seriously affect the patient's short- and long-term prognosis. NCCN guidelines recommend the use of sodium thiosulfate in all patients receiving HIPEC. This study intends to retrospectively collect clinical characteristics of patients to establish a prediction model for kidney injury, with a view to screening those at high risk of kidney injury for use of sodium thiosulfate for nephrotoxicity rescue in cisplatin HIPEC.

Interventions

PROCEDUREHyperthermic intraperitoneal chemotherapy

Patients diagnosed with FIGO Stage 3 or stage 4 ovarian cancer received hyperthermic intraperitoneal chemotherapy with cisplatin following cytoreductive surgery including primary debulking surgery, interval debulking surgery and secondary debulking surgery.

Sponsors

The First Affiliated Hospital of Bengbu Medical University
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients who received HIPEC with cisplatin following cytoreductive surgery. * Patients diagnosed with ovarian cancer pathologically. * FIGO stage III-IV.

Exclusion criteria

* Use of renal protective drugs such as sodium perthiosulfate. * Any grade of chronic or acute renal disease or other serious complications existed before HIPEC. * Patients with single kidney.

Design outcomes

Primary

MeasureTime frameDescription
Model prediction ProbabilityUp to 7 days within CRS-HIPECUsing the constructed clinical prediction model, the patient's baseline characteristics were input, and the model would output the probability of the patient developing AKI.
AUC (Area Under Curve)Up to 7 days within CRS-HIPECThe AUC value of the model was calculated using the ROC (Receiver Operating Characteristic) Curve.

Secondary

MeasureTime frameDescription
The incidence of AKI.Up to 7 days within CRS-HIPECThe AKI would be diagnosed according to KDIGO 2012 criteria.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026