End Stage Renal Disease on DialysisNCT04070690
The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
A study testing Concentration of dialysate bicarbonate in people with End Stage Renal Disease on Dialysis, run by Camillians Saint Mary's Hospital Luodong at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Concentration of dialysate bicarbonate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2019to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult uremic patients who received hemodialysis thrice weekly
Who cannot join
- 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.
Show all 10Show fewer
- Patients on steroids or other immunosuppressive therapy.
- Patients with recent surgery (within one month)
- Patients with an active bacterial infection.
- Patients with decompensated cirrhosis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Saint Mary's Hospital Luodong
Yilan, 265
Chih-Chung Shiao, MD, 913399253, chungyy2001@yahoo.com.tw
chungyy2001@yahoo.com.tw
About this study
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.
Read more
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
- Being tested
- Concentration of dialysate bicarbonate
- Keywords
- metabolic acidosis, sodium bicarbonate, hemodialysis, dialysate
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentration of dialysate bicarbonateProcedure or surgery
Adjust the dialysate bicarbonate concentration
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Concentration of dialysate bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure during the hemodialysis
Blood pressure will be measured every 1 hour during the hemodialysis
Measured: four months
Respiratory rate during the hemodialysis
Respiratory rate will be measured every 1 hour during the hemodialysis
Measured: four months
O2 saturation during the hemodialysis
O2 saturation will be measured every 1 hour during the hemodialysis
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camillians Saint Mary's Hospital Luodong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Chung Shiao, MD, Camillians Saint Mary's Hospital Luodong
- Investigators
- Chih-Chung Shiao, MD, Principal investigator, Saint Mary's Hospital Luodong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070690
- Sponsor's protocol ID
- SMHRF_107004
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The influences of dialysate bicarbonate concentrations on hemodialysis patients
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04070690
- Acronym / sponsor ID
- SMHRF_107004
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- metabolic acidosis, sodium bicarbonate, hemodialysis, dialysate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Camillians Saint Mary's Hospital LuodongUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Control group | Other | Procedure: Concentration of dialysate bicarbonateIn 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). |
| Control-Intervention group | Other | Procedure: Concentration of dialysate bicarbonateIn 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult uremic patients who received hemodialysis thrice weekly
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentration of dialysate bicarbonateAdjust the dialysate bicarbonate concentration | Procedure or surgery | Control-Intervention group, Intervention-Control group |
Primary outcome
Blood pressure during the hemodialysis
Time frame: four months
Blood pressure will be measured every 1 hour during the hemodialysis
Respiratory rate during the hemodialysis
Time frame: four months
Respiratory rate will be measured every 1 hour during the hemodialysis
O2 saturation during the hemodialysis
Time frame: four months
O2 saturation will be measured every 1 hour during the hemodialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No. The influences of dialysate bicarbonate concentrations on hemodialysis patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Chung Shiao, MD principal investigator
Saint Mary's Hospital Luodong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentration of dialysate bicarbonate in people with End Stage Renal Disease on Dialysis, run by Camillians Saint Mary's Hospital Luodong at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Chung Shiao, MD (+88639544106, chungyy2001@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure during the hemodialysis (time frame: four months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.