NCT07229040

A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatn Versus Thiosulfate in Patients Undergoing Debulking Surgery With Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Cisplatin.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin

Detailed description

A double-blind non inferiority clinical trial to compare the nephroprotection of cilastatn versus thiosulfate in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin.

Conditions

• Debulking Surgery for Ovarian Cancer
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	cilastatine	cilastatine 1.5 g
DRUG	tiosulfate	tiosulfate

Timeline

• Start date: 2025-02-21
• Primary completion: 2028-10-21
• Completion: 2028-10-21
• First posted: 2025-11-14
• Last updated: 2025-11-14

Locations

1 site across 1 country: Spain