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To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
EU CTIS ID: 2024-518854-18-00
What this study is testing
Non inferiority study of cilastatin versus Thiosulfate in reducing acute kidney damage (days 1-7) (creatinine levels and KDIGO scale) in patients treated with CRS+HIPEC-cisplatin during the immediate postoperative period.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: adult patients from 18-75 years
- Sex: Male/Female
- Eastern Cooperative Oncology Group Performance status (ECOG PS) # 2
- General situation of the patient: patient suitable for major surgery, with values of creatinine, bilirubin, blood series in a range close to normal (Hb>10g/dl, leucos >3000/ml, neutrals >1000/ml, platelets >100,000 /ml).
- Patients evaluated in the Anesthesia office and considered suitable for the intervention
- Signed informed consent
You likely can't join if
- Non-acceptance to participate in the clinical trial.
- ECOG PS > 2.
- Not suitable for major surgery.
- Disease not limited to the abdomen or with signs that it cannot be optimally cytoreduced (intestinal obstruction, biliary obstruction, ureteral obstruction, diffuse involvement of the small intestine or mesentery).
- Allergy to platinum.
- Patients with a neurological history who in the investigator's opinion are at risk of seizures associated with imipenem/cliastatin treatment.
See the full eligibility criteria
- Age: adult patients from 18-75 years
- Sex: Male/Female
- Eastern Cooperative Oncology Group Performance status (ECOG PS) # 2
- General situation of the patient: patient suitable for major surgery, with values of creatinine, bilirubin, blood series in a range close to normal (Hb>10g/dl, leucos >3000/ml, neutrals >1000/ml, platelets >100,000 /ml).
- Patients evaluated in the Anesthesia office and considered suitable for the intervention
- Signed informed consent
- Disease confined to the abdomen: CRS+HIPEC is not contemplated in patients with lung or bone metastases, etc.
- Evaluation in a Multidisciplinary Committee: radiological PCI is performed and it is estimated possibilities of complete cytoreduction, indicating CRS + HIPEC.
- Non-acceptance to participate in the clinical trial.
- ECOG PS > 2.
- Not suitable for major surgery.
- Disease not limited to the abdomen or with signs that it cannot be optimally cytoreduced (intestinal obstruction, biliary obstruction, ureteral obstruction, diffuse involvement of the small intestine or mesentery).
- Allergy to platinum.
- Patients with a neurological history who in the investigator's opinion are at risk of seizures associated with imipenem/cliastatin treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.