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.

NCT07229040 | Recruiting Phase 2

• 2 other identifiers: FIBHGM-ECNC001-20222024-518854-18-00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Debulking Surgery for Ovarian Cancer; Acute Kidney Injury

Outcome Measures

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.

  7 days

Study Arms (2)

cilastatin

EXPERIMENTAL

cilastatina 1,5 g

Drug: cilastatine

tiosulfate

ACTIVE COMPARATOR

tiosulfate

Drug: tiosulfate

Interventions

cilastatine DRUG

cilastatine 1.5 g

cilastatin

tiosulfate DRUG

tiosulfate

tiosulfate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hodpsital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cilastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Central Study Contacts

Alberto Lazaro, PhD

CONTACT

+34914265115; alazaro10@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non inferiority study of cilastatin versus Thiosulfate

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): October 21, 2028
• Study Completion (Estimated): October 21, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

ES (1)