Metabolic AcidosisNCT07779200
Bicarbonate HD Study
An observational study of Metabolic Acidosis and CKD on Hemodialysis Patients, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
The primary goal of this single centre observational study is to look at factors that affect serum bicarbonate levels in patients on maintenance dialysis. This will be done by collecting demographic information, relevant medical history, dialysis history, potential renal acid load from diet by recording different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Acidosis, CKD on Hemodialysis Patients
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with End Stage Renal Disease (ESRD) receiving maintenance dialysis at the study centre.
Who may be able to join
- Age 18 years and above.
- Ability to give informed consent.
- End Stage Renal Disease established on maintenance dialysis for at least 3 months.
- Patients on dialysis 3 times a week
Who cannot join
- Inability to give informed consent
- Patients with acute kidney injury
- Patients with severe COPD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB
Enric Vilar, 01438 284230 ext. 4230, enric.vilar@nhs.net
Simran Sorathia, 01438 284230 ext. 4230, simran.sorathia@nhs.net
About this study
Official title: Factors Affecting Bicarbonate Levels In Patients On Haemodialysis
The primary goal of this single centre observational study is to look at factors that affect serum bicarbonate levels in patients on maintenance dialysis. This will be done by collecting demographic information, relevant medical history, dialysis history, potential renal acid load from diet by recording different foods consumed over 2 days in a food diary and bicarbonate levels at 3 intervals, pre and post dialysis session 1 and pre dialysis session 2.
Bicarbonate levels are of significant interest as an indicator of metabolic acidosis in CKD dialysis patients. This study will allow us to understand the efficacy of different dialysis modalities in controlling bicarbonate levels. It will also enable us to understand the idea of individualizing dialysis for patients in terms of not using a standard concentration of dialysate for all patient undergoing dialysis in this center.
Read the detailed description
Cross sectional study
- Conditions
- Metabolic Acidosis, CKD on Hemodialysis Patients
- Medical subject headings
- Acidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum bicarbonate levels in patients on haemodialysis
Serum bicarbonate concentration measured across two dialysis sessions (HD1 and HD2) measured as Pre HD1, Post HD2 and Pre HD2.
Measured: 3 months
Secondary outcomes (3)
Dietary Acid Load
Potential renal acid load
Measured: ~ 3 months
Volume of Haemodiafiltration
Haemodiafiltration volume delivered
Measured: 3 months
Indicators of dialysis dose
Pre HD1 and Post HD1 serum urea
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start12 May 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779200
- Sponsor's protocol ID
- RD2025-72
- Other IDs
- 366999
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided after data analysis is complete
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Bicarbonate Levels In Patients On Haemodialysis
- ClinicalTrials.gov ID
- NCT07779200
- Acronym / sponsor ID
- RD2025-72
- Conditions
- Metabolic Acidosis, CKD on Hemodialysis Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 12 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Aug 2026 (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.
The primary goal of this single centre observational study is to look at factors that affect serum bicarbonate levels in patients on maintenance dialysis. This will be done by collecting demographic information, relevant medical history, dialysis history, potential renal acid load from diet by recording different foods consumed over 2 days in a food diary and bicarbonate levels at 3 intervals, pre and post dialysis session 1 and pre dialysis session 2.
Bicarbonate levels are of significant interest as an indicator of metabolic acidosis in CKD dialysis patients. This study will allow us to understand the efficacy of different dialysis modalities in controlling bicarbonate levels. It will also enable us to understand the idea of individualizing dialysis for patients in terms of not using a standard concentration of dialysate for all patient undergoing dialysis in this center.
Detailed description
Cross sectional study
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with End Stage Renal Disease (ESRD) receiving maintenance dialysis at the study centre.
Key inclusion criteria (4 listed)
- Age 18 years and above.
- Ability to give informed consent.
- End Stage Renal Disease established on maintenance dialysis for at least 3 months.
- Patients on dialysis 3 times a week
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Patients with acute kidney injury
- Patients with severe COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum bicarbonate levels in patients on haemodialysis
Time frame: 3 months
Serum bicarbonate concentration measured across two dialysis sessions (HD1 and HD2) measured as Pre HD1, Post HD2 and Pre HD2.
3 secondary outcomes
Dietary Acid Load
Time frame: ~ 3 months
Volume of Haemodiafiltration
Time frame: 3 months
Indicators of dialysis dose
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. To be decided after data analysis is complete
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Acidosis and CKD on Hemodialysis Patients, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enric Vilar (01438 284230 ext. 4230, enric.vilar@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum bicarbonate levels in patients on haemodialysis (time frame: 3 months). 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 13 Oct 2026.