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.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHospital General Universitario Gregorio Marañon

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • cilastatine

    Drug

    cilastatine 1.5 g

  • tiosulfate

    Drug

    tiosulfate

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: cilastatinExperimental treatment 1 intervention
Group B: tiosulfateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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