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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014