The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Camillians Saint Mary's Hospital Luodong

Status: Unknown

Conditions: End Stage Renal Disease on Dialysis

Treatments: Procedure: Concentration of dialysate bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT04070690

SMHRF_107004

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention-Control group

Other group

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).

Treatment:

Procedure: Concentration of dialysate bicarbonate

Control-Intervention group

Other group

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.

Treatment:

Procedure: Concentration of dialysate bicarbonate