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

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Acetate-free dialysis solution
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acetate-free solution first

Acetate-based solution first

Arm Description

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

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

Outcomes

Primary Outcome Measures

cardiac index
cardiac index and cardiac output was measured by ultrasound dilution technique
Cardiac output
cardiac index and cardiac output was measured by ultrasound dilution technique

Secondary Outcome Measures

blood pressure
peripheral vascular resistance
Patients' symptoms
dizziness, palpitation, nausea, cramp, numbness

Full Information

First Posted
December 20, 2012
Last Updated
February 12, 2013
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01778283
Brief Title
Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration
Official Title
Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetate-free solution first
Arm Type
Experimental
Arm Description
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
Arm Title
Acetate-based solution first
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Acetate-free dialysis solution
Intervention Description
the hemodialysis solution that does not contain acetate as buffer
Primary Outcome Measure Information:
Title
cardiac index
Description
cardiac index and cardiac output was measured by ultrasound dilution technique
Time Frame
6 months
Title
Cardiac output
Description
cardiac index and cardiac output was measured by ultrasound dilution technique
Time Frame
6 months
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
6 months
Title
peripheral vascular resistance
Time Frame
6 moths
Title
Patients' symptoms
Description
dizziness, palpitation, nausea, cramp, numbness
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
cardiac marker, serum electrolyte, inflammatory marker
Description
BUN, creatinine, serum sodium, serum potassium, serum bicarbonate, serum calcium, ionized calcium, serum magnesium, serum osmol, troponin T, NT-proBNP, CKMB, hs-CRP
Time Frame
January 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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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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