Status:
TERMINATED
Fluid Overload Management and Vascular Stiffness in Chronic Kidney Disease Patients With Hypertension
Lead Sponsor:
University of Alberta
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to reduce fluid overload in order to control blood pressure of hypertensive CKD patients using bio-impedance assessment of fluid status and using a diuretic therapy algorithm.
Detailed Description
Hypertension is highly prevalent in individuals with chronic kidney disease (CKD). Gradual loss of kidney function is associated with sodium retention. This ultimately leads to fluid overload which ha...
Eligibility Criteria
Inclusion
- Adult (\>18 years old) outpatient with uncontrolled hypertension; defined as, AMBP ≥ 130/80 mmHg despite treatment
- With an estimated glomerular filtration rate (eGFR) of 15-45 ml/min/1.73 m2.
- Fluid overload of more than 5% of estimated normal ECFV, as assessed by Bio-impedance spectroscopy (we are using the Body Composition Monitor, a validated device marketed by Fresenius, Canada).
Exclusion
- Pregnancy or lactation
- Declined informed consent
- Patients with cognitive dysfunction
- Surgery within six weeks of the study
- Patients with heart failure, atrial fibrillation, stroke, nephrotic syndrome and active auto-immune disease
- Patients with severe life-limiting comorbidities like cancer
- Patients with amputated limbs (despite the fact that the BCM device can be used if people have a unilateral amputation, the home devices measure via 2 legs).
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05378750
Start Date
November 1 2022
End Date
November 1 2023
Last Update
March 28 2024
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2P4