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.
Recruiting
Phase 2
Interventional Study
Debulking Surgery for Ovarian Cancer
Acute Kidney Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Hospital General Universitario Gregorio Marañon · Other
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About This Trial
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age: adult patients aged 18-75 years.
Sex: female. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2. General condition: patients eligible for major surgery, with creatinine, bilirubin, and blood count values within or close to the normal range (Hb \>10 g/dL…
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