Clinical trial NCT06697613: Development and Validation of a Prediction Model for AKI Following Cisplatin-Based HIPEC in Patients With Ovarian Cancer
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
AKI - Acute Kidney Injury
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Bengbu Medical University
First posted: 2024-11-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ovarian cancer were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with cisplatin.

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.


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.

Primary outcomes:
measure: Model prediction Probability
timeFrame: Up to 7 days within CRS-HIPEC
measure: AUC (Area Under Curve)
timeFrame: Up to 7 days within CRS-HIPEC
Secondary outcomes:
measure: The incidence of AKI.
timeFrame: Up to 7 days within CRS-HIPEC
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
citation: Colombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062.
citation: Zivanovic O, Chi DS, Filippova O, Randall LM, Bristow RE, O'Cearbhaill RE. It's time to warm up to hyperthermic intraperitoneal chemotherapy for patients with ovarian cancer. Gynecol Oncol. 2018 Dec;151(3):555-561. doi: 10.1016/j.ygyno.2018.09.007. Epub 2018 Sep 22.
citation: Lemoine L, Sugarbaker P, Van der Speeten K. Drugs, doses, and durations of intraperitoneal chemotherapy: standardising HIPEC and EPIC for colorectal, appendiceal, gastric, ovarian peritoneal surface malignancies and peritoneal mesothelioma. Int J Hyperthermia. 2017 Aug;33(5):582-592. doi: 10.1080/02656736.2017.1291999.
citation: Hod T, Freedberg KJ, Motwani SS, Chen M, Frendl G, Leaf DE, Gupta S, Mothi SS, Richards WG, Bueno R, Waikar SS. Acute kidney injury after cytoreductive surgery and hyperthermic intraoperative cisplatin chemotherapy for malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2021 Apr;161(4):1510-1518. doi: 10.1016/j.jtcvs.2020.05.033. Epub 2020 May 29.