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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01778283

Enrollment

Registered

2013-01-29

Start date

2012-10-31

Completion date

2012-11-30

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

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

Interventions

BIOLOGICALAcetate-free dialysis solution

the hemodialysis solution that does not contain acetate as buffer

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
cardiac index	6 months	cardiac index and cardiac output was measured by ultrasound dilution technique
Cardiac output	6 months	cardiac index and cardiac output was measured by ultrasound dilution technique

Secondary

Measure	Time frame	Description
blood pressure	6 months	—
peripheral vascular resistance	6 moths	—
Patients' symptoms	6 months	dizziness, palpitation, nausea, cramp, numbness

Other

Measure	Time frame	Description
cardiac marker, serum electrolyte, inflammatory marker	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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026