A Phase 2 Double-Blind Study Comparing Kidney Protection of Cilastatin Versus Thiosulfate in Women Undergoing Debulking Surgery with Heated Intraperitoneal Cisplatin Chemotherapy

What this Trial Is About

Researchers are comparing two drugs, cilastatin and thiosulfate, to see which better protects the kidneys in female patients undergoing debulking surgery combined with intraoperative hyperthermic intraperitoneal chemotherapy HIPEC using cisplatin. This phase 2, double-blind, randomized clinical trial evaluates whether cilastatin is not less effective than thiosulfate in preventing kidney damage in this setting. Participants receive either 1.5 grams of cilastatin or thiosulfate during their debulking surgery with HIPEC. The study uses a triple-blind design to prevent bias and randomly assigns patients to one of the two treatment groups. The main focus is on kidney protection during and after this specialized chemotherapy procedure, which targets tumors in the abdomen. During the study, researchers monitor patients for kidney failure within the first seven days after surgery to measure the primary outcome. Patients are assessed for overall health and eligibility before surgery, and kidney function is carefully tracked. The total participant age range is 18 to 75 years, and only females diagnosed with ovarian cancer suitable for this surgery are included. The study runs until October 2028 with ongoing monitoring and evaluation.

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.