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Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00237783
Enrollment
4
Registered
2005-10-12
Start date
2005-10-31
Completion date
2008-10-31
Last updated
2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Hypotension

Keywords

Renal dialysis, Hypotension, Dialysis solutions

Brief summary

Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.

Detailed description

Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control. In this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 2 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.

Interventions

DRUGdialysate sodium (140 mmol/L)
DRUGindividualized dialysate sodium

individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Hemodialysis patients with intradialytic hypotension

Exclusion criteria

* Atrial fibrillation * Bilateral upper extremity arteriovenous access * Average plasma sodium \>139

Design outcomes

Primary

MeasureTime frame
Intradialytic BP changefrom study onset through intervention, week 7

Secondary

MeasureTime frame
Intradialytic changes in cardiac output and peripheral vascular resistancefrom study onset through intervention, week 7
Interdialytic weight gain changefrom study onset through intervention, week 7
Thirst scoresfrom study onset through intervention, week 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026