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临床试验/NCT06697613
NCT06697613已完成不适用

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 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Model prediction Probability

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Model prediction Probability

时间窗: 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)

时间窗: Up to 7 days within CRS-HIPEC

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing Li

Professor

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

研究点 (1)

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