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Clinical Trials/NCT04070690
NCT04070690
Unknown
Not Applicable

The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Camillians Saint Mary's Hospital Luodong1 site in 1 country60 target enrollmentAugust 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Renal Disease on Dialysis
Sponsor
Camillians Saint Mary's Hospital Luodong
Enrollment
60
Locations
1
Primary Endpoint
Blood pressure during the hemodialysis
Last Updated
6 years ago

Overview

Brief Summary

Background:

Patients with decreased kidney function are in the positive acid balance due to insufficient renal acid excretion. To correct the varying degrees of metabolic acidosis in these HD patients, a high concentration of HCO3 in the dialysate is routinely used.

During every 3-to-4 hours of HD treatment, a massive surge of HCO3 would enter the circulation and typically overcorrects predialysis acidosis to alkalosis and alkalemia.

The sharp acid-base shift can cause some adverse consequences.

The investigators believe that the rapid correction (or overcorrection) from the pre-dialysis metabolic acidosis to post-dialysis metabolic alkalosis during the 3-to-4 hours HD treatment would relate to adverse effects on HD patients.

Thus the investigators conduct this study to prove the hypothesis that "prevention of post-dialysis alkalosis by using lower dialysate HCO3 concentration might cause less adverse outcomes in ESRD patients on HD."

Study design:

Prospective cross-over case-control study.

Study population:

A total of 60 patients who receive regular hemodialysis (three times per week) for more than 6 months in the regional teaching hospital.

Registry
clinicaltrials.gov
Start Date
August 2019
End Date
February 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chih-Chung Shiao, MD

Director, Dept. of Medical Research and Education, Saint Mary's Hospital Luodong

Camillians Saint Mary's Hospital Luodong

Eligibility Criteria

Inclusion Criteria

  • adult uremic patients who received hemodialysis thrice weekly

Exclusion Criteria

  • Hospitalized patients
  • Patients newly initiated on HD (\<6 months)
  • Patients with HD access problems
  • Patients recently discharged from the hospital (within one month).
  • Patients on chemotherapy for cancer.
  • Patients with a kidney transplant.
  • Patients on steroids or other immunosuppressive therapy.
  • Patients with recent surgery (within one month)
  • Patients with an active bacterial infection.
  • Patients with decompensated cirrhosis.

Outcomes

Primary Outcomes

Blood pressure during the hemodialysis

Time Frame: four months

Blood pressure will be measured every 1 hour during the hemodialysis

O2 saturation during the hemodialysis

Time Frame: four months

O2 saturation will be measured every 1 hour during the hemodialysis

Respiratory rate during the hemodialysis

Time Frame: four months

Respiratory rate will be measured every 1 hour during the hemodialysis

Study Sites (1)

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