Effect of Citrate Dialysate on Vascular Calcification

Emory University

Status: Completed

Conditions: Vascular Calcification

Treatments: Device: Citrate Dialysate; Device: Standard Dialysate

Study type: Interventional

Funder types: Other

Identifiers

NCT04956120

STUDY00002119

Details and patient eligibility

About

The goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured on mammograms that will be performed at 6-month intervals and additional blood samples will be obtained at 6-month intervals.

Full description

Vascular calcification is a significant problem in dialysis patients that leads to poor outcomes. Currently there is no therapy that directly addresses this problem. Some of the dialysis solutions (dialysates) currently in use contain citrate, a potent inhibitor of calcium precipitation. In particular, citrate can bind to nascent hydroxyapatite crystals and prevent their propagation. Blood citrate levels are greater after dialysis with citrate dialysates than with non-citrate dialysates, which could slow vascular calcification. However, this has never been investigated. Prior research has shown that arterial calcification can be easily detected and reliably measured on routine digital mammograms, with sufficient sensitivity to follow progression. Mammography is more sensitive in detecting arterial calcification than other imaging and associated with far less radiation and cost. This will allow the researchers to detect differences between citrate and non-citrate dialysates in a safe and convenient way. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured by mammography every 6 months. The endpoint will be the difference in the rate of progression of breast arterial calcification (BAC) between dialysis with citrate and non-citrate dialysates.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hemodialysis patients with BAC on mammograms

Exclusion criteria

• current warfarin use
• severe hyperparathyroidism (likely to undergo parathyroidectomy in the next 2 years)
• difficulty controlling serum calcium (likely to require changes in dialysate calcium concentration in the next 2 years)
• life expectancy < 2 years
• prisoners
• inability to give consent

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Citrate Dialysate then Standard Dialysate

Experimental group

Description:

Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.

Treatment:

Device: Standard Dialysate

Device: Citrate Dialysate

Standard Dialysate then Citrate Dialysate

Active Comparator group

Description:

Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.

Treatment:

Device: Standard Dialysate

Device: Citrate Dialysate