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Study on the Effects of Intraperitoneal Furosemide in Patients with Heart Failure on Peritoneal Dialysis

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Furosemide Sodium in patients who are undergoing a treatment known as peritoneal dialysis. Peritoneal dialysis is a procedure used to remove waste products and excess fluid from the blood when the kidneys are not functioning properly. The study is particularly interested in patients who also have heart failure, a condition where the heart is unable to pump blood effectively.

The purpose of the study is to compare the effects of administering Furosemide Sodium directly into the abdominal cavity (intraperitoneally) versus taking it orally. The study will observe how this medication affects the body's fluid levels and overall hydration status. Participants will receive the medication for a period of up to 30 days. During this time, various health indicators will be monitored, including body weight, blood pressure, and the presence of swelling (oedema). Advanced techniques like ultrasound and bioimpedance will be used to assess fluid levels in the body.

Additionally, the study will measure certain biochemical markers in the blood, such as CA125 and NT-proBNP, which can indicate fluid congestion in the body. The trial aims to provide valuable insights into the safety and effectiveness of using Furosemide Sodium in this new way, potentially offering improved treatment options for patients on peritoneal dialysis with heart failure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed based on specific criteria such as age, current treatment, and health status.
Participants must be over 18 years old, on a stable dose of oral furosemide (at least 120 mg daily) for the past 15 days, and have a functioning peritoneal dialysis (PD) catheter.
Participants must have a residual urine output greater than 500 ml per day and have completed a peritoneal equilibrium test in the last three months.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements.
This includes evaluating body fluid volume, weight, blood pressure, presence of swelling (oedema), and other health indicators using bioimpedance and ultrasound.
Step 3
Medication administration
Participants receive furosemide sodium administered intraperitoneally, which means it is delivered directly into the abdominal cavity.
The dosage and frequency are determined by the study protocol and are monitored throughout the trial.
Step 4
Ongoing monitoring
Regular monitoring is conducted to assess the effectiveness and safety of the treatment.
Measurements include changes in body fluid volume, weight, blood pressure, and urine output over 24 hours.
Additional tests may include ultrasound evaluations and biochemical markers of fluid congestion.
Step 5
Final assessment
At the end of the trial, a final assessment is conducted to evaluate the overall impact of the treatment.
This includes a comprehensive review of all health indicators measured throughout the study.

Who can join the trial?

7 criteria

Patients must be taking a daily dose of at least 120 mg of **furosemide** by mouth for the past fifteen days. **Furosemide** is a medication that helps remove excess fluid from the body.
Patients must be over 18 years old.
Patients must be clinically stable while using **PD technique**. **PD technique** refers to **peritoneal dialysis**, a treatment for kidney failure that uses the lining of your abdomen to filter waste from your blood.
Patients must have a **normofunctioning PD catheter**. This means the tube used for peritoneal dialysis is working properly.
Patients must have a **residual diuresis** greater than 500 ml per day. **Residual diuresis** is the amount of urine the kidneys can still produce.
Patients must have completed a **peritoneal equilibrium test** in the last three months. This test checks how well the peritoneal dialysis is working.
Patients must be willing to participate and sign the informed consent form, which explains the study and confirms their agreement to join.

Who cannot join the trial?

4 criteria

Patients who are not stable in their current health condition.
Patients who are not receiving treatment in a PD unit. A PD unit is a place where patients receive a type of dialysis treatment called peritoneal dialysis.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population. This means people who might need special protection or care.

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Hospital Universitario Dr Peset Aleixandre
Valencia, Spain

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Investigated drugs

Furosemide: This medication is commonly used to help remove excess fluid from the body. In this trial, it is being studied to see how effective it is when given directly into the abdominal cavity (intraperitoneally) compared to taking it by mouth (orally). The goal is to understand how it affects the hydration status of patients who are on peritoneal dialysis, which is a treatment for kidney failure.

What is already known about the treatment

Furosemide – Furosemide is administered intraperitoneally, which means it is delivered directly into the peritoneal cavity, and it can also be taken orally. It is currently being studied in clinical trials to assess its efficacy and safety for patients undergoing peritoneal dialysis, particularly those with heart failure. The main therapeutic indication for furosemide is to manage fluid retention and swelling caused by heart failure, liver disease, or kidney disease. At the molecular level, furosemide works by inhibiting the reabsorption of sodium and chloride in the kidneys, leading to increased urine production and reduced fluid buildup. It is classified as a loop diuretic, which is a type of medication that helps remove excess fluid from the body.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying heart conditions that weaken or damage the heart muscle. As the condition progresses, individuals may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and abdomen. The heart may become enlarged, and fluid can accumulate in the lungs and other parts of the body. Over time, the heart's ability to function continues to decline, leading to increased symptoms and reduced physical activity. Management focuses on improving heart function and reducing symptoms.