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

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

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Biological: Acetate-free dialysis solution

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: Acetate-free dialysis solution; the hemodialysis solution that does not contain acetate as buffer
Active Comparator: 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	Biological: Acetate-free dialysis solution; the hemodialysis solution that does not contain acetate as buffer

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac marker, serum electrolyte, inflammatory marker	BUN, creatinine, serum sodium, serum potassium, serum bicarbonate, serum calcium, ionized calcium, serum magnesium, serum osmol, troponin T, NT-proBNP, CKMB, hs-CRP	January 2013

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimate): January 29, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 297/55