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Completed

NCT Number: NCT01778283

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

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetate-free dialysis solution

Biological

the hemodialysis solution that does not contain acetate as buffer

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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