Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

— D-Bic-T50-HD  

Official title:

Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06084858
• Other study ID #: D-Bic-T50-HD
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Elisabethinen Hospital
• Contact: Alexandra Dumfarth, PMSc
• Phone: 00437327676
• Email: alexandra.dumfarth[@]ordensklinikum.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Dialysate bicarbonate modification
Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Priv. Doz. Dr. Daniel Cejka

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T50-Laboratory Test for measuring calcification	The intra-individual difference of T50-times between low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription.	6 Weeks
Secondary	CPP Levels	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.	6 Weeks