Study Comparing Cilastatin and Sodium Thiosulfate for Kidney Protection in Patients Undergoing Surgery with Chemotherapy Using Cisplatin

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What is this study about?

This clinical trial is focused on studying the effects of two treatments, cilastatin and thiosulfate, in protecting the kidneys of patients undergoing a specific type of cancer surgery. The surgery involves removing as much of the tumor as possible, known as debulking surgery, and is followed by a heated chemotherapy treatment inside the abdomen using a drug called cisplatin. This procedure is known to potentially cause acute kidney injury, which is a sudden decrease in kidney function.

The purpose of the study is to compare how well cilastatin and thiosulfate protect the kidneys during this treatment. Participants will receive either cilastatin or thiosulfate during their surgery. The study will monitor kidney function by measuring levels of a substance called creatinine in the blood, which indicates how well the kidneys are working. The study will also use a scale called the KDIGO scale to assess kidney health. The main focus is on the first week after surgery, but if there are signs of kidney problems, monitoring will continue for up to two weeks.

Throughout the study, researchers will also look at other factors, such as any side effects from the treatments and differences in how the body processes cisplatin between the two groups. The study aims to provide valuable information on which treatment offers better protection for the kidneys during this complex cancer treatment.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

2 pre-surgery evaluation

Before the surgery, a thorough evaluation will be conducted to ensure you are suitable for the procedure. This includes checking your general health status, such as creatinine and bilirubin levels, and ensuring your blood counts are within a normal range.

3 surgery and treatment

You will undergo a major surgery known as debulking surgery, followed by a procedure called hyperthermic intraperitoneal chemotherapy (HIPEC) with a drug called cisplatin. During this time, you will receive one of two medications: Imipenem/Cilastatin Kabi or Sodium Thiosulfate Hope Pharmaceuticals.

Both medications are administered as a solution for infusion, which means they are given through a drip into your vein. The specific dosage and frequency will be determined by the medical team based on your individual needs.

4 postoperative monitoring

After the surgery, your kidney function will be closely monitored for up to 7 days. This involves measuring your creatinine levels and using a scale called KDIGO to assess any potential kidney damage.

If any signs of kidney damage are detected, monitoring may continue until the 14th day after surgery.

5 follow-up and assessment

Throughout the study, various assessments will be conducted to compare the effects of the two medications on kidney protection. This includes analyzing blood and urine samples to measure different markers of kidney function.

You will also be monitored for any side effects or adverse reactions related to the study treatment.

Who Can Join the Study?

Age: Adult patients between 18 and 75 years old.
Sex: Only female patients can participate.
Health Status: Patients must have an ECOG Performance Status of 2, which means they are capable of all self-care but unable to carry out any work activities. They are up and about more than 50% of waking hours.
General Health: Patients should be suitable for major surgery and have nearly normal levels of creatinine (a waste product measured to check kidney function), bilirubin (a substance made during the normal breakdown of red blood cells), and blood counts (hemoglobin >10g/dl, white blood cells >3000/ml, neutrophils >1000/ml, platelets >100,000/ml).
Pre-Surgery Evaluation: Patients must be evaluated in the Anesthesia office and considered suitable for the surgery.
Consent: Patients must have signed an informed consent, which means they agree to participate in the study after being informed about all aspects of the trial.
Disease Location: The disease must be confined to the abdomen. The study does not include patients with cancer spread to the lungs or bones. It may include patients with limited spread to the blood, spleen, or liver, or if the cancer has spread to nearby lymph nodes or within the abdomen, as long as complete removal is possible.
Multidisciplinary Evaluation: Patients must be evaluated by a team of specialists to assess the possibility of complete cancer removal, indicating the need for the specific treatment being studied.

Who Cannot Join the Study?

Patients with acute kidney injury cannot participate. This means if you have a sudden decrease in kidney function, you are not eligible.
Only female patients are eligible. Male patients cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital General Universitario Gregorio Maranon	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	21.10.2024

Trial locations

Investigated drugs:

Cilastatin is a medication used in this clinical trial to help protect the kidneys. It works by preventing the breakdown of certain antibiotics in the kidneys, which can help reduce the risk of kidney damage. In this study, it is being tested to see if it can protect the kidneys as effectively as another medication when patients are undergoing a specific type of cancer treatment.

Thiosulfate is another medication being tested in the trial for its ability to protect the kidneys. It is known to help neutralize certain harmful substances in the body, which can help prevent damage to the kidneys. The trial aims to determine if thiosulfate can provide similar kidney protection as cilastatin during a particular cancer treatment process.

Investigated diseases:

Acute kidney injury

Acute kidney Injury – Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. The condition can occur due to a variety of causes, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. As the condition progresses, patients may experience decreased urine output, swelling due to fluid retention, and fatigue. In severe cases, it can lead to an accumulation of waste products in the blood, which can affect other organs and systems. The progression of acute kidney injury can vary, with some cases resolving quickly while others may lead to more prolonged kidney dysfunction.

Trial ID:

2024-518854-18-00

Protocol code:

FIBHGM-ECNC001-2022

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Cilastatin and Sodium Thiosulfate for Kidney Protection in Patients Undergoing Surgery with Chemotherapy Using Cisplatin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?