Study on the Effects of Intraperitoneal Furosemide in Patients with Heart Failure on Peritoneal Dialysis
- Participants:Adults
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Furosemide sodium is a loop diuretic, a type of medicine that increases the amount of urine the body produces. It is an authorised medicine, meaning it has been approved for use by medicines regulators.[1] The name furosemide sodium appears in the EU Clinical Trials Information System as the product name for the investigational medicinal product used in the registered trial.[1] In the United Kingdom, furosemide is available as 20 mg tablets for oral use, as recorded in the NHS dm+d medicines database.[2]
Furosemide belongs to the group of medicines called loop diuretics. These medicines act on the kidneys to increase the removal of salt and water from the body through urine. This reduces the amount of fluid in the blood vessels and tissues, which helps lower blood pressure and relieve swelling caused by fluid build-up. The prescribing guide from East and North Hertfordshire NHS Trust notes that bumetanide, another loop diuretic, has actions and uses similar to those of furosemide, and that 1 mg of bumetanide produces a diuretic effect similar to 40 mg of furosemide.[3]
Furosemide is used to treat conditions where excess fluid accumulates in the body. The registered clinical trial is studying it specifically in two overlapping conditions:
The trial focuses on stable patients in a peritoneal dialysis unit who are being treated for fluid overload related to heart failure.[1]
In the registered trial, furosemide sodium is given by intraperitoneal use, meaning it is delivered directly into the peritoneal cavity, the space inside the abdomen where dialysis fluid is exchanged.[1] The trial uses a dose of 120 mg. Furosemide is also commonly given by mouth, as shown by the 20 mg oral tablets listed in the NHS medicines database.[2] The NHS prescribing guide describes intravenous infusion of furosemide, which must be given slowly at a rate not exceeding 4 mg per minute to avoid damage to hearing (ototoxicity).[3]
One Phase 3 trial is registered in the EU Clinical Trials Information System under the identifier 2024-519356-87-00.[1] Phase 3 means the medicine is being tested in a larger group of people to confirm how well it works and how safe it is. The trial is currently authorised, meaning it has received approval to begin.[1]
The trial plans to enrol 37 participants who are stable patients in a peritoneal dialysis unit.[1] It compares furosemide given intraperitoneally with furosemide given orally, to see which route is better at controlling hydration status.[1]
The trial measures several outcomes: reduction in body fluid volume, weight, blood pressure, presence of oedema (swelling), bioimpedance values (a measure of body fluid), ultrasound values including the venous excess ultrasound score (VEXUS) and lung ultrasound, and biochemical markers of congestion called CA125 and NT-proBNP.[1] These measurements help researchers understand how well the medicine removes excess fluid from the body.
The prescribing guide from East and North Hertfordshire NHS Trust mentions that furosemide given intravenously can cause ototoxicity, which is damage to hearing, if the infusion is given too quickly.[3] The guide states that the infusion rate should not exceed 4 mg per minute to avoid this effect, and in patients with severe impairment of renal function, the rate should not exceed 2.5 mg per minute.[3] The registered trial data does not provide a list of side effects for the intraperitoneal route, as the trial is designed to study both efficacy and safety.[1]
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