The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Sponsor

Camillians Saint Mary's Hospital Luodong (Other)

Overall Status

Unknown status

CT.gov ID

NCT04070690

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease on Dialysis	Procedure: Concentration of dialysate bicarbonate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	Procedure: Concentration of dialysate bicarbonate Adjust the dialysate bicarbonate concentration
Other: 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.	Procedure: Concentration of dialysate bicarbonate Adjust the dialysate bicarbonate concentration

Arm

Intervention/Treatment

Other: 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).

Procedure: Concentration of dialysate bicarbonate

Adjust the dialysate bicarbonate concentration

Other: 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.

Procedure: Concentration of dialysate bicarbonate

Adjust the dialysate bicarbonate concentration

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Mary's Hospital Luodong	Yilan		Taiwan	265

Sponsors and Collaborators

Camillians Saint Mary's Hospital Luodong

Investigators

Principal Investigator: Chih-Chung Shiao, MD, Saint Mary's Hospital Luodong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chih-Chung Shiao, MD, Director, Dept. of Medical Research and Education, Saint Mary's Hospital Luodong, Camillians Saint Mary's Hospital Luodong

ClinicalTrials.gov Identifier:

NCT04070690

Other Study ID Numbers:

SMHRF_107004

First Posted:

Aug 28, 2019

Last Update Posted:

Aug 28, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chih-Chung Shiao, MD, Director, Dept. of Medical Research and Education, Saint Mary's Hospital Luodong, Camillians Saint Mary's Hospital Luodong

Additional relevant MeSH terms:

Kidney Failure, Chronic

Dialysis Solutions

Study Results

No Results Posted as of Aug 28, 2019