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.

To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Debulking Surgery for Ovarian Cancer
• Intervention / Treatment: Drug: cilastatine; Drug: tiosulfate

Detailed Description

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
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alberto Lazaro, PhD; Phone Number: +34914265115; Email: alazaro10@gmail.com

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28007
      • Recruiting
      • Hodpsital General Universitario Gregorio Marañón
      • Contact: Alberto Lazaro, PHD; Phone Number: +34914265115
      • Contact: Email: alazaro10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, leukocytes >3,000/mL, neutrophils >1,000/mL, platelets >100,000/mL).

Patients evaluated by the Anesthesiology Department and deemed fit for surgery. Signed informed consent. Disease confined to the abdomen: CRS + HIPEC is not indicated in patients with pulmonary, bone, or other distant metastases. Patients with limited hematogenous metastases to the spleen or liver may be considered. Patients with regional or distant intra-abdominal lymphatic dissemination may also be considered, provided complete resection is feasible. FIGO stage IVA epithelial ovarian carcinoma at presentation, due to pleural effusion with mediastinal lymph node or splenic metastases, is an indication for neoadjuvant chemotherapy; if response is achieved, CRS + HIPEC may subsequently be considered.

Multidisciplinary Committee evaluation: radiological PCI is assessed, and the likelihood of achieving complete cytoreduction is estimated to determine the indication for CRS + HIPEC.

Exclusion Criteria:

• 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).

Known hypersensitivity to platinum-based agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cilastatin; cilastatina 1,5 g	Drug: cilastatine; cilastatine 1.5 g
Active Comparator: tiosulfate	Drug: tiosulfate; tiosulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): October 21, 2028
• Study Completion (Estimated): October 21, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 14, 2025

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Organic Chemicals; Fatty Acids; Lipids; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Fatty Acids, Unsaturated; Fatty Acids, Monounsaturated; Cyclopropanes; Cilastatin
• Other Study ID Numbers: FIBHGM-ECNC001-2022; 2024-518854-18-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No