Clinical trial NCT00237783: Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension
Official title: Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hemodialysis
Hypotension
Keywords: Renal dialysis
Hypotension
Dialysis solutions
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients with intradialytic hypotension

Exclusion Criteria:

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

Primary outcomes:
measure: Intradialytic BP change
timeFrame: from study onset through intervention, week 7
Secondary outcomes:
measure: Intradialytic changes in cardiac output and peripheral vascular resistance
timeFrame: from study onset through intervention, week 7
measure: Interdialytic weight gain change
timeFrame: from study onset through intervention, week 7
measure: Thirst scores
timeFrame: from study onset through intervention, week 7
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University and VA Connecitcut Healthcare System
name: Aldo J Peixoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. doi: 10.1111/j.1523-1755.2004.00876.x.