RecruitingPhase 2NCT07229040
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.
Sponsor
Hospital General Universitario Gregorio Marañon
Enrollment
90 participants
Start Date
Feb 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years
Plain Language Summary
Simplified for easier understanding
This study compares two kidney-protecting drugs — cilastatin versus thiosulfate — in women with ovarian cancer who are receiving a specialized treatment called HIPEC (hyperthermic intraperitoneal chemotherapy with cisplatin) during surgery. The goal is to find out which drug better protects the kidneys from cisplatin damage.
**You may be eligible if...**
- You are a woman between 18 and 75 years old
- You have ovarian cancer confined to the abdomen and are eligible for cytoreductive surgery with HIPEC
- Your general health is adequate for major surgery (normal or near-normal blood counts and organ function)
- A multidisciplinary team has reviewed your case and determined HIPEC is appropriate
**You may NOT be eligible if...**
- You have cancer spread outside the abdomen (e.g., to the lungs or bones)
- You are not medically fit for major surgery
- Your general health score is poor (ECOG > 2)
- You do not consent to participate
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGcilastatine
cilastatine 1.5 g
DRUGtiosulfate
tiosulfate
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07229040
Related Trials
Acute Normovolemic Hemodilution on Urine Neutrophil Gelatinase-associated Lipocalin Levels
NCT053492921 location
Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial
NCT063378383 locations
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
NCT064467399 locations
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
NCT0575807738 locations
Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support
NCT068402101 location