The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Not Applicable

• Conditions: End Stage Renal Disease on Dialysis

• 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

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-24
• Last Update Submitted: 2019-08-24
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-01
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood pressure during the hemodialysis	four months	Blood pressure will be measured every 1 hour during the hemodialysis
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

Trial Locations

Locations (1)

Saint Mary's Hospital Luodong; 🇨🇳 Yilan, Taiwan