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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Khajohn Tiranathanagul, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01778283
First received: December 20, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
End-stage Renal Disease
Biological: Acetate-free dialysis solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • cardiac index [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    cardiac index and cardiac output was measured by ultrasound dilution technique

  • Cardiac output [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    cardiac index and cardiac output was measured by ultrasound dilution technique


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • peripheral vascular resistance [ Time Frame: 6 moths ] [ Designated as safety issue: Yes ]
  • Patients' symptoms [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    dizziness, palpitation, nausea, cramp, numbness


Other Outcome Measures:
  • cardiac marker, serum electrolyte, inflammatory marker [ Time Frame: January 2013 ] [ Designated as safety issue: Yes ]
    BUN, creatinine, serum sodium, serum potassium, serum bicarbonate, serum calcium, ionized calcium, serum magnesium, serum osmol, troponin T, NT-proBNP, CKMB, hs-CRP


Enrollment: 22
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778283

Locations
Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
  More Information

No publications provided

Responsible Party: Khajohn Tiranathanagul, Doctor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01778283     History of Changes
Other Study ID Numbers: 297/55
Study First Received: December 20, 2012
Last Updated: February 12, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 15, 2014