NCT07779200

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

July 2, 2026

Last Update Submit

August 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Dietary Acid Load

    ~ 3 months

  • Volume of Haemodiafiltration

    3 months

  • Indicators of dialysis dose

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients with End Stage Renal Disease (ESRD) receiving maintenance dialysis at the study centre.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to give informed consent
  • Patients with acute kidney injury
  • Patients with severe COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

August 21, 2026

Study Start

May 12, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

August 21, 2026

Record last verified: 2026-08

Locations