The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

NCT ID: NCT04070690

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-02-29

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.

Conditions

End Stage Renal Disease on Dialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Concentration of dialysate bicarbonate

Intervention Type: PROCEDURE

Adjust the dialysate bicarbonate concentration

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.

Group Type: OTHER

Concentration of dialysate bicarbonate

Intervention Type: PROCEDURE

Adjust the dialysate bicarbonate concentration

Interventions

Concentration of dialysate bicarbonate

Adjust the dialysate bicarbonate concentration

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Camillians Saint Mary's Hospital Luodong

OTHER

Sponsor Role: lead

Responsible Party

Chih-Chung Shiao, MD

Director, Dept. of Medical Research and Education, Saint Mary's Hospital Luodong

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Chung Shiao, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Mary's Hospital Luodong

Locations

Saint Mary's Hospital Luodong

Yilan, , Taiwan

Countries

Taiwan

Central Contacts

Chih-Chung Shiao, MD

Role: CONTACT

chungyy2001@yahoo.com.tw

+88639544106

Facility Contacts

Chih-Chung Shiao, MD

Role: primary

chungyy2001@yahoo.com.tw

913399253

Role: backup

chungyy2001@yahoo.com.tw

Other Identifiers

SMHRF_107004

Identifier Type: -

Identifier Source: org_study_id