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

NCT01778283 | Completed Phase 4 DMC

• 1 other identifier: 297/55
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• cardiac index

  cardiac index and cardiac output was measured by ultrasound dilution technique

  6 months

• Cardiac output

  cardiac index and cardiac output was measured by ultrasound dilution technique

  6 months

Secondary Outcomes (3)

• blood pressure

  6 months

• peripheral vascular resistance

  6 moths

• Patients' symptoms

  6 months

Other Outcomes (1)

• cardiac marker, serum electrolyte, inflammatory marker

  January 2013

Study Arms (2)

Acetate-free solution first

EXPERIMENTAL

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

Acetate-based solution first

ACTIVE COMPARATOR

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

Interventions

Acetate-free dialysis solution BIOLOGICAL

the hemodialysis solution that does not contain acetate as buffer

Acetate-based solution first; Acetate-free solution first

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 29, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

TH (1)