Back to resultsEffect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients (D-Bic-T50-HD)
Primary Purpose
End Stage Renal Disease
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dialysate bicarbonate modification
Sponsored by
About this trial
This is an interventional diagnostic trial for End Stage Renal Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dialysate Bicarbonat modification
Arm Description
Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06084858
First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Prim. Priv. Doz. Dr. Daniel Cejka
1. Study Identification
Unique Protocol Identification Number
NCT06084858
Brief Title
Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Acronym
D-Bic-T50-HD
Official Title
Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Priv. Doz. Dr. Daniel Cejka
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dialysate Bicarbonat modification
Arm Type
Experimental
Arm Description
Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion
Intervention Type
Other
Intervention Name(s)
Dialysate bicarbonate modification
Intervention Description
Dialysate bicarbonate prescription will be modified from low (27 mmol/l) to high (37 mmol/l) in a step-wise fashion
Primary Outcome Measure Information:
Title
T50-Laboratory Test for measuring calcification
Description
The intra-individual difference of T50-times between low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
CPP Levels
Description
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.
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Dumfarth, PMSc
Phone
00437327676
Ext
4302
Email
alexandra.dumfarth@ordensklinikum.at
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Cejka, MD
Phone
00437327676
Ext
4300
Email
daniel.cejka@ordensklinikum.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cejka, MD
Organizational Affiliation
Head of Nephrology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
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