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

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ClinicalTrials.gov Identifier: NCT01778283
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Khajohn Tiranathanagul, Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Biological: Acetate-free dialysis solution Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




Primary Outcome Measures :
  1. cardiac index [ Time Frame: 6 months ]
    cardiac index and cardiac output was measured by ultrasound dilution technique

  2. Cardiac output [ Time Frame: 6 months ]
    cardiac index and cardiac output was measured by ultrasound dilution technique


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 6 months ]
  2. peripheral vascular resistance [ Time Frame: 6 moths ]
  3. Patients' symptoms [ Time Frame: 6 months ]
    dizziness, palpitation, nausea, cramp, numbness


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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778283


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

Responsible Party: Khajohn Tiranathanagul, Doctor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01778283     History of Changes
Other Study ID Numbers: 297/55
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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