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

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778283
• Other study ID #: 297/55
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2012
• Last updated: February 12, 2013
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Biological:
• Acetate-free dialysis solution
the hemodialysis solution that does not contain acetate as buffer

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cardiac marker, serum electrolyte, inflammatory marker	BUN, creatinine, serum sodium, serum potassium, serum bicarbonate, serum calcium, ionized calcium, serum magnesium, serum osmol, troponin T, NT-proBNP, CKMB, hs-CRP	January 2013	Yes
Primary	cardiac index	cardiac index and cardiac output was measured by ultrasound dilution technique	6 months	Yes
Primary	Cardiac output	cardiac index and cardiac output was measured by ultrasound dilution technique	6 months	Yes
Secondary	blood pressure		6 months	Yes
Secondary	peripheral vascular resistance		6 moths	Yes
Secondary	Patients' symptoms	dizziness, palpitation, nausea, cramp, numbness	6 months	Yes