Status:
COMPLETED
Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Intradialytic Hypertension
End Stage Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk ...
Detailed Description
This is an interventional randomized crossover study performed in the Department of Nephrology, Hippokration Hospital, Thessaloniki, Greece. For the purposes of this study, adult patients (\>18 years)...
Eligibility Criteria
Inclusion
- Adult ESKD individuals treated with a standard thrice weekly hemodialysis schedule for at least 3 months
- Patients with intradialytic hypertension, defined as SBP rise ≥10 mmHg from pre- to post-dialysis in at least 4 out of 6 consecutive sessions
- Patients that are considered clinically euvolemic
- Ability to provide informed written consent
Exclusion
- Post-dialysis SBP \<130 mmHg in at least 4 out of 6 consecutive sessions during the 2-week selection period, prior to study entry
- Previous non-functional arteriovenous fistula in the contralateral brachial arm area of the one used for vascular access that could interfere with proper ambulatory BP recording
- Patients with contraindications to receive the intervention (low dialysate sodium), i.e patients with frequent intradialytic hypotension episodes requiring intervention with fluid administration
- Pre-dialysis serum sodium \<130 or \>142 mEq/L at recruitment
- Modification of dry weight or antihypertensive treatment during one month before study initiation
- History of seizures or disequilibrium syndrome
- Hospitalization for any cause during one month before study initiation
- History of malignancy or any other condition with poor prognosis
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05430438
Start Date
June 1 2022
End Date
July 24 2023
Last Update
October 16 2024
Active Locations (4)
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1
Frontis Dialysis Center
Athens, Greece, 18757
2
Therapeutiki Dialysis Unit
Thessaloniki, Greece, 56532
3
Aristotle University of Thessaloniki
Thessaloniki, Greece
4
UKC Maribor
Maribor, Slovenia, 2000