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Clinical Trials/NCT06697613
NCT06697613
Completed
Not Applicable

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country150 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
150
Locations
1
Primary Endpoint
Model prediction Probability
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
August 31, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jing Li

Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Model prediction Probability

Time Frame: Up to 7 days within CRS-HIPEC

Using 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)

Time Frame: Up to 7 days within CRS-HIPEC

The AUC value of the model was calculated using the ROC (Receiver Operating Characteristic) Curve.

Secondary Outcomes

  • The incidence of AKI.(Up to 7 days within CRS-HIPEC)

Study Sites (1)

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