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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: End-stage Renal Disease

Treatments: Biological: Acetate-free dialysis solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01778283

297/55

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

Acetate-free solution first

Experimental group

Description:

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

Treatment:

Biological: Acetate-free dialysis solution

Acetate-based solution first

Active Comparator group

Description:

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

Treatment:

Biological: Acetate-free dialysis solution