To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
cilastatine 1.5 g
tiosulfate
Hodpsital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
RECRUITINGPercentage of patients with renal failure at 7 days
Percentage of patients with renal failure at 7 days (If renal impairment is present, follow-up continues until postoperative day 14), assessed based on serum creatinine levels and KDIGO classification criteria. Renal failure is defined as an increase in serum creatinine to 1.5-1.9 times the baseline value, or an increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L), or a reduction in urine output to \<0.5 mL/kg/hour for 6 to 12 hours.
Time frame: 7 days
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