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NCT Number: NCT06697613

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

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.

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Key information

Conditions

Ovarian Cancer AKI - Acute Kidney Injury Acute Kidney Injury Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Renal Insufficiency Urogenital Diseases Urogenital Neoplasms Urologic Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperthermic Intraperitoneal Chemotherapy

Procedure

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.

Primary outcomes

  1. 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.

  2. 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

  1. The incidence of AKI.

    Time frame: Up to 7 days within CRS-HIPEC

    The AKI would be diagnosed according to KDIGO 2012 criteria.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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