The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

NCT04070690 | Unknown

• 1 other identifier: SMHRF_107004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

metabolic acidosis; sodium bicarbonate; hemodialysis; dialysate

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention-Control group

OTHER

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

Control-Intervention group

OTHER

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

Interventions

Concentration of dialysate bicarbonate PROCEDURE

Adjust the dialysate bicarbonate concentration

Control-Intervention group; Intervention-Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult uremic patients who received hemodialysis thrice weekly

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camillians Saint Mary's Hospital Luodong: lead

Study Sites (1)

Saint Mary's Hospital Luodong

Yilan, 265, Taiwan

Location

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chih-Chung Shiao, MD

  Saint Mary's Hospital Luodong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Chung Shiao, MD

CONTACT

+88639544106; chungyy2001@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dept. of Medical Research and Education, Saint Mary's Hospital Luodong

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)