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

NCT ID: NCT01778283

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-11-30

Brief Summary

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

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acetate-free solution first

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

Group Type: EXPERIMENTAL

Acetate-free dialysis solution

Intervention Type: BIOLOGICAL

the hemodialysis solution that does not contain acetate as buffer

Acetate-based solution first

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

Group Type: ACTIVE_COMPARATOR

Acetate-free dialysis solution

Intervention Type: BIOLOGICAL

the hemodialysis solution that does not contain acetate as buffer

Interventions

Acetate-free dialysis solution

the hemodialysis solution that does not contain acetate as buffer

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Khajohn Tiranathanagul

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

297/55

Identifier Type: -

Identifier Source: org_study_id