The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Procedure: Concentration of dialysate bicarbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention-Control group<br>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). | Procedure: Concentration of dialysate bicarbonate<br>* Adjust the dialysate bicarbonate concentration<br>|
| Other: Control-Intervention group<br>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. | Procedure: Concentration of dialysate bicarbonate<br>* Adjust the dialysate bicarbonate concentration<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic acidosis, sodium bicarbonate, hemodialysis, dialysate