FUROSEMIDE SODIUM for Peritoneal dialysis|Heart failure

Inclusion criteria

• {"criterion_text":"- Patients on treatment with a daily dose equal to or higher than 120 mg of stable oral furosemide during previous fifteen days ."}
• {"criterion_text":"- Patients over 18 years of age"}
• {"criterion_text":"- Clinically stable patients in PD technique"}
• {"criterion_text":"- Patients with a normofunctioning PD catheter"}
• {"criterion_text":"- Patients with residual diuresis greater than 500ml per day"}
• {"criterion_text":"- Patients who have undergone a peritoneal equilibrium test in the previous three months"}
• {"criterion_text":"- Patients who wish to participate and who sign the informed consent form"}

Exclusion criteria

• {"criterion_text":"- Allergy to furosemide"}
• {"criterion_text":"- Inability of the patient or caregiver to administer intraperitoneal therapy at home"}
• {"criterion_text":"- Need to modify the rest of the oral diuretic treatment at the time of inclusion in the study and during follow-up"}

Primary endpoints

• {"endpoint_text":"- efficiency and safety measures","definition_or_measurement_approach":""}
• {"endpoint_text":"- reduction in body fluid volume","definition_or_measurement_approach":""}
• {"endpoint_text":"- weight","definition_or_measurement_approach":""}
• {"endpoint_text":"- blood preasure","definition_or_measurement_approach":""}
• {"endpoint_text":"- presence of oedema","definition_or_measurement_approach":""}
• {"endpoint_text":"- bioimpedance values","definition_or_measurement_approach":""}
• {"endpoint_text":"- ultrasound values (venous excess ultrasound score, VEXUS, and lung ultrasound)","definition_or_measurement_approach":"Venous Excess Ultrasound Score (VEXUS) and lung ultrasound assessments (as stated in endpoint text)."}
• {"endpoint_text":"- biochemical markers of congestion: CA125 and NT-proBNP","definition_or_measurement_approach":"Measurement of biochemical markers CA125 and NT-proBNP (as stated in endpoint text)."}

Secondary endpoints

• {"endpoint_text":"- other measures of interest","definition_or_measurement_approach":""}
• {"endpoint_text":"- Increased diuresis: 24-hour urine volume, 24-hour urine sodium","definition_or_measurement_approach":"Measured by 24-hour urine volume and 24-hour urine sodium (as stated)."}

Spain

Earliest CTIS Part Ii Submission Date

19-12-2024

Latest Decision Or Authorization Date

04-03-2025

Processing Time Days

75

Number Of Sites

1

Number Of Participants

37

Primary sponsor

Full Name

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain