Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

Yale University

Status and phase: Terminated; Phase 1

Conditions: Hypotension; Hemodialysis

Treatments: Drug: dialysate sodium (140 mmol/L); Drug: individualized dialysate sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00237783

AP0008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemodialysis patients with intradialytic hypotension

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

standard dialysate sodium (140 mmol/L)

Active Comparator group

Description:

dialysate sodium (140 mmol/L)

Treatment:

Drug: dialysate sodium (140 mmol/L)

individualized dialysate sodium

Experimental group

Description:

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

Treatment:

Drug: individualized dialysate sodium