Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

Phase 1

Terminated

• Conditions: Hemodialysis; Hypotension
• Interventions: Drug: dialysate sodium (140 mmol/L); Drug: individualized dialysate sodium

• Registration Number: NCT00237783
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Hemodialysis patients with intradialytic hypotension

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
standard dialysate sodium (140 mmol/L)	dialysate sodium (140 mmol/L)	dialysate sodium (140 mmol/L)
individualized dialysate sodium	individualized dialysate sodium	individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)

Primary Outcome Measures

Name	Time	Method
Intradialytic BP change	from study onset through intervention, week 7

Secondary Outcome Measures

Name	Time	Method
Intradialytic changes in cardiac output and peripheral vascular resistance	from study onset through intervention, week 7
Interdialytic weight gain change	from study onset through intervention, week 7
Thirst scores	from study onset through intervention, week 7

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States