search
Back to results

The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Concentration of dialysate bicarbonate
Sponsored by
Camillians Saint Mary's Hospital Luodong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis focused on measuring metabolic acidosis, sodium bicarbonate, hemodialysis, dialysate

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Mary's Hospital Luodong

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention-Control group

Control-Intervention group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Blood pressure during the hemodialysis
Blood pressure will be measured every 1 hour during the hemodialysis
Respiratory rate during the hemodialysis
Respiratory rate will be measured every 1 hour during the hemodialysis
O2 saturation during the hemodialysis
O2 saturation will be measured every 1 hour during the hemodialysis

Secondary Outcome Measures

Full Information

First Posted
August 5, 2019
Last Updated
August 24, 2019
Sponsor
Camillians Saint Mary's Hospital Luodong
search

1. Study Identification

Unique Protocol Identification Number
NCT04070690
Brief Title
The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
Official Title
The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Camillians Saint Mary's Hospital Luodong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
metabolic acidosis, sodium bicarbonate, hemodialysis, dialysate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention-Control group
Arm Type
Other
Arm Description
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).
Arm Title
Control-Intervention group
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Concentration of dialysate bicarbonate
Intervention Description
Adjust the dialysate bicarbonate concentration
Primary Outcome Measure Information:
Title
Blood pressure during the hemodialysis
Description
Blood pressure will be measured every 1 hour during the hemodialysis
Time Frame
four months
Title
Respiratory rate during the hemodialysis
Description
Respiratory rate will be measured every 1 hour during the hemodialysis
Time Frame
four months
Title
O2 saturation during the hemodialysis
Description
O2 saturation will be measured every 1 hour during the hemodialysis
Time Frame
four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Chung Shiao, MD
Phone
+88639544106
Email
chungyy2001@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Chung Shiao, MD
Organizational Affiliation
Saint Mary's Hospital Luodong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Mary's Hospital Luodong
City
Yilan
ZIP/Postal Code
265
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Chung Shiao, MD
Phone
913399253
Email
chungyy2001@yahoo.com.tw
Ext
Shiao
Email
chungyy2001@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Chih-Chung Shiao, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The influences of dialysate bicarbonate concentrations on hemodialysis patients

Learn more about this trial

The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

We'll reach out to this number within 24 hrs