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Study on Reducing Fluid Use During Cancer Surgery with Argipressin for Patients with Disseminated Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The HiPRESS study is focused on patients with disseminated cancer, which refers to cancer that has spread from its original site to other parts of the body. The study is investigating a treatment involving a medication called argipressin, also known as arginine vasopressin. This medication is being tested to see if it can reduce the amount of fluid given to patients during a specific type of surgery called cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). This surgery is used to remove as much of the cancer as possible and is followed by heated chemotherapy applied directly inside the abdomen.

The purpose of the study is to determine if using low doses of argipressin can decrease the total amount of fluid needed during the surgery compared to the standard treatment with another medication called noradrenaline. The study will involve patients who are scheduled to undergo CRS-HIPEC surgery. During the study, some patients will receive argipressin, while others will receive a placebo or the standard treatment. The effects of these treatments will be monitored to see if there is a difference in the amount of fluid required during the operation.

Participants in the study will be observed for various outcomes, including the total fluid given during surgery, fluid balance after surgery, and any signs of fluid overload. The study will also look at potential complications, such as abdominal or lung issues, and the overall recovery quality. The length of hospital stay and any serious complications up to 30 days after surgery will also be recorded. The study aims to provide valuable information on whether argipressin can improve the management of fluid levels during this complex cancer surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins when scheduled for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC).
Step 2
Preparation for surgery
Before surgery, preparation involves standard medical assessments to ensure readiness for the procedure.
Step 3
Administration of medication
During surgery, a low dose of argipressin is administered through an infusion. This medication is used to potentially reduce the amount of fluid needed during the operation.
Step 4
Surgery and fluid management
The main goal is to manage fluid levels during the operation. The total amount of fluids, including crystalloids and blood products, is carefully monitored.
Step 5
Postoperative monitoring
After surgery, fluid balance is assessed on the day of surgery and on the first and third days after surgery. This includes checking for signs of fluid overload using ultrasound.
Complications are monitored, including abdominal and pulmonary issues, as well as kidney function up to five days post-surgery.
Step 6
Recovery assessment
Recovery quality is evaluated on the third day after surgery using a specific questionnaire.
The length of stay in the hospital and intensive care unit is recorded, along with any major complications up to 30 days post-surgery.
Step 7
Follow-up
The study tracks outcomes such as 30-day mortality and overall recovery progress.

Who can join the trial?

5 criteria

The patient must have **disseminated cancer**, which means cancer that has spread to other parts of the body.
The patient must be scheduled to undergo **CRS-HIPEC** surgery. This is a type of surgery used to treat certain cancers in the abdomen.
The patient must be within the age range of 18 to 64 years old.
Both **male** and **female** patients can participate.
The patient should not be part of a vulnerable population, meaning they should not have additional conditions that make them more at risk.

Who cannot join the trial?

1 criterion

Patients with disseminated cancer cannot participate. This means cancer that has spread to different parts of the body.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Vasopressin
is a medication used in this trial to see if it can help reduce the amount of fluids given to patients during a specific type of cancer surgery. It works by helping to control blood pressure and reduce the need for extra fluids.
Noradrenaline
is another medication used in the trial as a standard treatment. It helps maintain blood pressure during surgery, ensuring that the body functions properly even when fluid levels are controlled.

Argipressin

What is already known about the treatment

Argipressin – Argipressin is administered intravenously and is being studied for its potential to reduce fluid requirements during specific cancer surgeries. It is currently under investigation in clinical trials, particularly in the context of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy. The main therapeutic indication is to manage fluid balance during surgery for disseminated cancer. At the molecular level, argipressin works by mimicking the action of the natural hormone vasopressin, which helps regulate water retention and blood pressure. It is classified pharmacologically as a vasopressor agent.

Investigated diseases

Disseminated Cancer – Disseminated cancer refers to cancer that has spread from its original site to other parts of the body. This process, known as metastasis, can involve various organs and tissues, leading to a more complex disease state. The spread occurs through the bloodstream or lymphatic system, allowing cancer cells to establish new tumors in distant locations. As the disease progresses, it can affect the function of the involved organs, leading to a range of symptoms depending on the areas affected. The progression of disseminated cancer can vary widely depending on the type of cancer and the extent of spread. Understanding the specific pathways and mechanisms of metastasis is crucial for managing the disease.