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

Completed

• Conditions: Ovarian Cancer; AKI - Acute Kidney Injury

• Registration Number: NCT06697613
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Model prediction Probability	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)	Up to 7 days within CRS-HIPEC	The AUC value of the model was calculated using the ROC (Receiver Operating Characteristic) Curve.

Secondary Outcome Measures

Name	Time	Method
The incidence of AKI.	Up to 7 days within CRS-HIPEC	The AKI would be diagnosed according to KDIGO 2012 criteria.

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China