The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

August 24, 2019 updated by: Chih-Chung Shiao, MD, Camillians Saint Mary's Hospital Luodong

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention-Control group

In this group, the participants will receive "intervention" for 2 months first, followed by a wash-out period of 1 month and "control" for 2 months.

In the "intervention period," the investigators will provide the participants with lower dialysate HCO3 concentrations. (dialysate HCO3 to 28 mmol/L for half of the HD session and 30 to the second half of their HD session.) Besides, the investigators will give the participants with pre-HD HCO3<22 mEq/L oral Na-bicarbonate 650 mg 1#-2# three times a day as supplements.

In the "control period," the investigators will provide the participants with dialysate HCO3 concentration of 38-40 mEq/L (as we usually provide to patients).

Adjust the dialysate bicarbonate concentration
Other: Control-Intervention group

In this group, the participants will receive "control" for 2 months first, followed by a wash-out period of 1 month and "intervention" for 2 months.

In the "control period," the investigators will provide the participants with dialysate HCO3 concentration of 38-40 mEq/L (as we usually provide to patients).

In the "intervention period," the investigators will provide the participants with lower dialysate HCO3 concentrations. (dialysate HCO3 to 28 mmol/L for half of the HD session and 30 to the second half of their HD session.) Besides, the investigators will give the participants with pre-HD HCO3<22 mEq/L oral Na-bicarbonate 650 mg 1#-2# three times a day as supplements.

Adjust the dialysate bicarbonate concentration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure during the hemodialysis
Time Frame: four months
Blood pressure will be measured every 1 hour during the hemodialysis
four months
Respiratory rate during the hemodialysis
Time Frame: four months
Respiratory rate will be measured every 1 hour during the hemodialysis
four months
O2 saturation during the hemodialysis
Time Frame: four months
O2 saturation will be measured every 1 hour during the hemodialysis
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chih-Chung Shiao, MD, Saint Mary's Hospital Luodong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 24, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 24, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The influences of dialysate bicarbonate concentrations on hemodialysis patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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