Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

NCT ID: NCT00237783

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-10-31

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.

Conditions

Hemodialysis; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard dialysate sodium (140 mmol/L)

dialysate sodium (140 mmol/L)

Group Type: ACTIVE_COMPARATOR

dialysate sodium (140 mmol/L)

Intervention Type: DRUG

individualized dialysate sodium

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

Group Type: EXPERIMENTAL

individualized dialysate sodium

Intervention Type: DRUG

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

Interventions

dialysate sodium (140 mmol/L)

Intervention Type: DRUG

individualized dialysate sodium

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Hemodialysis patients with intradialytic hypotension

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo J Peixoto, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University and VA Connecitcut Healthcare System

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15327422 (View on PubMed)

Other Identifiers

AP0008

Identifier Type: -

Identifier Source: org_study_id