A Phase 2 interventional study of cilastatine and tiosulfate in Debulking Surgery for Ovarian Cancer and Acute Kidney Injury, sponsored by Hospital General Universitario Gregorio Marañon. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Hospital General Universitario Gregorio Marañon · Phase 2, Interventional, and Treatment
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Hospital General Universitario Gregorio Marañon is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Sex: female. Performance Status (ECOG PS) ≤ 2. General condition: patients eligible for major surgery, with creatinine, , and blood count values within or close to the normal range ( >10 g/dL, leukocytes >3,000/mL, neutrophils >1,000/mL, >100,000/mL).
Patients evaluated by the Anesthesiology Department and deemed fit for surgery. Signed . Disease confined to the abdomen: CRS + HIPEC is not indicated in patients with pulmonary, bone, or other distant . 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 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:
Known to platinum-based agents.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cilastatina 1,5 g
Drug: cilastatine
tiosulfate
Drug: tiosulfate
cilastatine 1.5 g
tiosulfate
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Oct 2028, 44 months after the start.
Of 39 non-industry phase 2 interventional studies under Acute Kidney Injury, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's planned 44 months is above that.
Counting every sponsor, half of 57 studies reached it within 29 months; a quarter within 16 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Hospital General Universitario Gregorio Marañon