Clinical trial NCT04956120: Effect of Citrate Dialysate on Vascular Calcification
Official title: Effect of Citrate Dialysate on Vascular Calcification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Calcification
Keywords: Hemodialysis
Breast arterial calcification
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Renal Therapies Group (FMCRTG)
First posted: 2021-07-09
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Calcified Artery Segments
timeFrame: Month 0 (baseline), Month 6, Month 12, Month 18, Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Dialysis at Northside
state: Georgia
city: Atlanta
country: United States
facility: Emory Dialysis at Greenbriar
state: Georgia
city: Decatur
country: United States
facility: Emory Dialysis at North Decatur
state: Georgia
city: Decatur
country: United States
facility: Emory Dialysis at Candler
state: Georgia
Study officials:
affiliation: Emory University
name: W. Charles O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References: