Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

Hypotension Clinical Trial

Official title:

Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00237783
• Other study ID #: AP0008
• Status: Terminated
• Phase: Phase 1
• First received: October 7, 2005
• Last updated: July 25, 2016
• Start date: October 2005
• Est. completion date: October 2008

Study information

• Verified date: July 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Hemodialysis patients with intradialytic hypotension

Exclusion Criteria:

• Atrial fibrillation

• Bilateral upper extremity arteriovenous access

• Average plasma sodium >139

Study Design

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

Related Conditions & MeSH terms

• Hemodialysis
• Hypotension

Intervention

Drug:
• dialysate sodium (140 mmol/L)

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

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Kidney Int. 2004 Nov;66(5):2108. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intradialytic BP change		from study onset through intervention, week 7	No
Secondary	Intradialytic changes in cardiac output and peripheral vascular resistance		from study onset through intervention, week 7	No
Secondary	Interdialytic weight gain change		from study onset through intervention, week 7	No
Secondary	Thirst scores		from study onset through intervention, week 7	No