About this trial
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: adult patients aged 18-75 years.
Disqualifiers
Lack of consent to participate in the clinical trial. Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 2. Not eligible for major surgery. Disease not confined to the abdomen, or with findings indicating that optimal cytoreduction is not achievable (e.g., intestinal obstruction, biliary obstruction, ureteral obstruction, or diffuse involvement of the small bowel or mesentery).
Trial design
Parallel
Treatments tested in this trial
cilastatine
Drugcilastatine 1.5 g
tiosulfate
Drugtiosulfate
Treatment groups
Trial outcomes
Primary outcomes
Percentage 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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.