The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04070690
• Other study ID #: SMHRF_107004
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: February 2020

Study information

• Verified date: August 2019
• Source: Camillians Saint Mary's Hospital Luodong
• Contact: Chih-Chung Shiao, MD
• Phone: +88639544106
• Email: chungyy2001[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Procedure:
• Concentration of dialysate bicarbonate
Adjust the dialysate bicarbonate concentration

Locations

Country	Name	City	State
Taiwan	Saint Mary's Hospital Luodong	Yilan

Sponsors (1)

Lead Sponsor	Collaborator
Camillians Saint Mary's Hospital Luodong

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure during the hemodialysis	Blood pressure will be measured every 1 hour during the hemodialysis	four months
Primary	Respiratory rate during the hemodialysis	Respiratory rate will be measured every 1 hour during the hemodialysis	four months
Primary	O2 saturation during the hemodialysis	O2 saturation will be measured every 1 hour during the hemodialysis	four months