- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070690
The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chih-Chung Shiao, MD
- Phone Number: +88639544106
- Email: chungyy2001@yahoo.com.tw
Study Locations
-
-
-
Yilan, Taiwan, 265
- Saint Mary's Hospital Luodong
-
Contact:
- Chih-Chung Shiao, MD
- Phone Number: 913399253
- Email: chungyy2001@yahoo.com.tw
-
Contact:
- Email: chungyy2001@yahoo.com.tw
-
Principal Investigator:
- Chih-Chung Shiao, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Chih-Chung Shiao, MD, Saint Mary's Hospital Luodong
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMHRF_107004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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