NCT02334267

Acid-Base Composition With Use of hemoDialysates

Acid-Base Composition With Use of hemoDialysates: the ABChD Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Fresenius Medical Care North America · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid dialysate concentrates in prevalent hemodialysis patients.

Detailed description

Approximately 10-20 prevalent hemodialysis patients will be recruited. Subjects will randomized to receive one weekly hemodialysis treatment using each of the two acetate acid dialysate buffers of NaturaLyte and GranuFlo, which will be assigned in a random fashion. Acetate and bicarbonate concentrations will be assessed before, at eight time points during, and six time points after the completion of hemodialysis.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Group 1: GranuFlo	Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.
DEVICE	Group 2: NaturaLyte	Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-02-01
• Completion: 2015-09-01
• First posted: 2015-01-08
• Last updated: 2017-03-09
• Results posted: 2017-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study