Safety of Dialysate Sodium Individualization in Hemodialysis Patients With

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00237783
Study type	Interventional
Source	Yale University
Contact
Status	Terminated
Phase	Phase 1
Start date	October 2005
Completion date	October 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms