The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
- Conditions
- End Stage Renal Disease on Dialysis
- Interventions
- Procedure: Concentration of dialysate bicarbonate
- Registration Number
- NCT04070690
- Lead Sponsor
- Camillians Saint Mary's Hospital Luodong
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- adult uremic patients who received hemodialysis thrice weekly
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention-Control group Concentration of dialysate bicarbonate 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). Control-Intervention group Concentration of dialysate bicarbonate 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.
- Primary Outcome Measures
Name Time Method Respiratory rate during the hemodialysis four months Respiratory rate will be measured every 1 hour during the hemodialysis
O2 saturation during the hemodialysis four months O2 saturation will be measured every 1 hour during the hemodialysis
Blood pressure during the hemodialysis four months Blood pressure will be measured every 1 hour during the hemodialysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Saint Mary's Hospital Luodong
🇨🇳Yilan, Taiwan