Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

Technical University of Munich

Status: Unknown

Conditions: End Stage Renal Disease (ESRD)

Treatments: Other: Acetate by Citrate substitution and vice versa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02745340

344/15s

Details and patient eligibility

About

Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide. It has been published in small trials or case series that the addition of acetate is associated with a rise in nitric oxide production of vascular smooth muscle cells, endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure drops, induction of proinflammatory cytokines and activation of complement and leukocytes have been described with acetate.

Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis), Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects. Both dialysate additives (citrate and acetate) are commercially available and are used world wide in dialysis centers.

The investigators hypothesize that substitution of acetate by citrate reduces the cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity and Augmentation index) and might improves quality of life in the participants. Furthermore the investigators speculate that citrate in the dialysis solution could reduce systemic inflammation in the participants of the study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• time since initiation of dialysis > 3 months
• age > 18 years
• dialysis 3x/week for > 4 hrs

Exclusion criteria

• ongoing infection
• pregnancy
• lack of written and informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Acetate

Active Comparator group

Treatment:

Other: Acetate by Citrate substitution and vice versa

Citrate

Experimental group

Treatment:

Other: Acetate by Citrate substitution and vice versa