Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Study Overview
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Brief Summary
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The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac index and cardiac output measured by saline dilution techniques compares with Acetate-based solution in online-hemodiafiltration

Official Title
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Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Biological: Acetate-free dialysis solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End-stage renal disease patients with age over 20 years and stable clinical status Dialytic age > 6 months Maintenance hemodialysis with online-hemodiafiltration mode at King Chulalongkorn Memorial Hospital Use arteriovenous fistula or arteriovenous graft as vascular access for hemodialysis No vascular access recirculation No liver impairment No severe, intractable metabolic acidosis or alkalosis (HCO3 <15, >30) No pre-existing severe, intractable hypocalcemia (Ca < 7.5) or clinical of hypocalcemia Exclusion Criteria: On hemodialysis via tunnel catheter Vascular access recirculation Liver dysfunction Severe, intractable metabolic acidosis or alkalosis (HCO3 <15, >30) Pre-existing severe, intractable hypocalcemia (Ca < 7.5) or clinical of hypocalcemia Acute or recent myocardial ischemia or congestive heart failure (within 1 months) Threatening arrhythmia (VT, VF, sustained SVT, AF with rapid ventricular response) Patients affected by acute or chronic infections, malignant tumor

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetate-free solution first<br>Acetate-free solution first : hemodialysis 4 hours with Acetate-free solution (Acetate 0 mEq/L Citrate 2 mEq/L) at the first session after enrollment, and then switch to Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the next 4-hr hemodialysis session | Biological: Acetate-free dialysis solution<br>* the hemodialysis solution that does not contain acetate as buffer<br>|
| Active Comparator: Acetate-based solution first<br>Acetate-based solution first : hemodialysis 4 hours with Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the first session after enrollment, and then switch to Acetate-free solution (Acetate 2 mEq/L Citrate 2 mEq/L) at the next 4-hr hemodialysis session | Biological: Acetate-free dialysis solution<br>* the hemodialysis solution that does not contain acetate as buffer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index | cardiac index and cardiac output was measured by ultrasound dilution technique | 6 months | 
| Cardiac output | cardiac index and cardiac output was measured by ultrasound dilution technique | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 6 months | 
| peripheral vascular resistance |  | 6 moths | 
| Patients' symptoms | dizziness, palpitation, nausea, cramp, numbness | 6 months |