This study aims to examine the effect of furosemide on renal PBUT excretion and PBUT plasma levels in patients with CKD.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of this study are PBUT plasma levels (indoxyl sulphate,
p-cresyl sulphate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric
acid en p-cresyl glucuronide) pre- and post-furosemide treatment
Secondary outcome
- Fractional PBUT excretion pre- and post-furosemide administration
- Surrogate PBUT clearance pre- and post-furosemide administration
- PBUT protein binding pre- and post-furosemide administration.
Background summary
Protein-bound uremic toxins are known to accumulate in chronic kidney disease
(CKD) and are associated with increased morbidity and mortality. It is
therefore crucial to maintain the PBUT levels low in this patient group.
Furosemide is often prescribed to CKD patients. However, based on preclinical
data, furosemide could affect the renal excretion of PBUTs, either by competing
for the secretory system in the kidney or by competing for binding to albumin.
It is important to examine the effect of furosemide on the excretion and plasma
concentration PBUTs as this might have harmful consequences for patients with
CKD.
Study objective
This study aims to examine the effect of furosemide on renal PBUT excretion and
PBUT plasma levels in patients with CKD.
Study design
This study is observational and includes invasive measurements; a prospective
repeated measures cohort study design will be used in which PBUT plasma
concentration and excretion will be determined before and after the start of
furosemide treatment.
Study burden and risks
Participants will only receive furosemide prescribed by their treating
physician as part of routine patient care. In addition, three blood sample
drawings and collection of two urine samples and two 12-hour urine collections
will be needed. Thus, the risk associated with participation is negligibly low
and will include two site visits. These visits will be combined with routine
check-ups as much as possible. Participants will receive 30 euros as a
compensation (based on the expected time investment and minimum wage) and a
travel allowance for all additional visits.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
• An age of 18 years or older
• An eGFR <60 mL/min/1.73m2 for at least three months (diagnosis of CKD stage
3-5)
• An indication for the start of treatment with furosemide as part of routine
patient care
• Willingness to participate in the study and a signed informed consent
Exclusion criteria
• Patients who are already on furosemide treatment
• Patients with a liver disease with hyperbilirubinemia
• Patients who receive any type of renal replacement therapy (peritoneal
dialysis, haemodialysis)
• Patients with end-stage renal failure without residual diuresis
• Patients who will start with medication simultaneously with start of
furosemide treatment that might interfere with PBUT excretion or PBUT protein
binding
• Patients who are incapacitated
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81338.041.23 |