End Stage Renal Disease
Conditions
Brief summary
This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.
Detailed description
This single-arm, proof-of-principle study will be conducted at the dialysis facility of the Ordensklinikum Linz Elisabethinen Hospital. The dialysate bicarbonate prescription will be decreased from standard of care (usually 35mmol/l) in a stepwise fashion (2 mmol/l per change) to 27 mmol/l and subsequentially increased in a stepwise fashion (2 mmol/l per change) to 37 mmol/l over the course of 6 weeks.
Interventions
OTHERDialysate bicarbonate modification
Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion
Sponsors
Prim. Priv. Doz. Dr. Daniel Cejka
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a single-center, prospective, proof-of-priciple, pilot study. Bicarbonate for dialysis will be modified step-by-step from 27 mmol/l to 37 mmol/l.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years * chronic (≥3 months) treatment with hemodialysis or hemodiafiltration * stable clinical condition
Exclusion criteria
* inability to provide informed consent * dialysis treatment less than thrice weekly * morbid obesity (body mass index \>40 kg/m2) * chronic inflammation (C reactive protein \>10 mg/dL, reference: \<0.5 g/dL) * current immunosuppressive medication, * severe chronic obstructive pulmonary disease (COPD stage III or IV) * history of severe hypercapnia or hypoxemia * overt congestive heart failure * history of severe hypokalemia (\<3.0 mmol/l) or hyperkalemia (\>6.5 mmol/L) within 3 months prior to study inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T50-Laboratory Test for measuring calcification | 6 Weeks | The intra-individual difference of T50-times between low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CPP Levels | 6 Weeks | The difference in intra-dialytic change in CPP levels with low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription, while the inter-dialytic differences in CPP levels with low and high dialysate bicarbonate prescriptions will be tertiary endpoints. |
Countries
Austria
Outcome results
None listed