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.
NCT07229040 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-11-14
Summary
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
Conditions
- Debulking Surgery for Ovarian Cancer
- Acute Kidney Injury
Interventions
- DRUG
-
cilastatine
cilastatine 1.5 g
- DRUG
-
tiosulfate
tiosulfate
Sponsors & Collaborators
-
Hospital General Universitario Gregorio Marañon
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-21
- Primary Completion
- 2028-10-21
- Completion
- 2028-10-21
Countries
- Spain
Study Locations
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