Effects of Oral Sodium Bicarbonate Supplementation in Haemodialysis Patients (BicHD) (BicHD)

September 30, 2016 updated by: Imperial College Healthcare NHS Trust

A Feasibility Randomised Controlled Trial: Effects of Oral Sodium Bicarbonate Supplementation in Patients on Haemodialysis

The purpose of the study is to investigate whether oral sodium bicarbonate supplementation to ensure a constant bicarbonate profile in haemodialysis patients will primarily lower predialysis potassium levels and secondary lead to improvements in cardiac function, muscle mass and dialysis related symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

One of the functions of dialysis is to correct electrolyte abnormalities which occur with renal failure, such as variations in potassium and bicarbonate levels, which are linked to important clinical outcomes for patients. Metabolic acidosis, reflected by falling bicarbonate levels, is a frequent event in haemodialysis patients and its correction is one of the goals of effective dialysis. Bicarbonate replacement is routinely delivered during each dialysis session thrice weekly with the use of high dialysate bicarbonate. However, local and national data show that over 50% of patients fail to meet a bicarbonate level within the normal range before each dialysis session. Low predialysis bicarbonate levels of less than 22mmols/L have been linked with increased all-cause mortality in haemodialysis patients.

Evidence from previous studies suggests that a continuous replacement (i.e. daily) with oral sodium bicarbonate capsules may be a superior correction of acidosis to the current treatment of intermittent replacement during dialysis.

Aims and objectives:

This randomised controlled study aims to investigate the effects of oral sodium bicarbonate supplementation on:

Primary objective: Pre and post dialysis potassium without increasing intradialytic potassium gradient.

Secondary objectives:

  1. Risk of arrhythmia as measured by ECG analysis
  2. Muscle mass as measured by body composition monitoring
  3. Muscle function as measured by handgrip strength
  4. Haemodialysis related cramps as measured by a symptom scale-renal questionnaire

Patients will be recruited from Imperial College Healthcare NHS (National Heath Service) Trust haemodialysis units and randomised to two equally numbered groups. One group will receive the standard dialysis treatment (control) and the other one will receive the standard dialysis with the addition of capsules of sodium bicarbonate (intervention). The dose of sodium bicarbonate will be adjusted according to individual levels. The study duration is 16 weeks.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients on haemodialysis for at least 3 months, Patients who primarily have predialysis bicarbonate levels of less than 22mmols/L over the last 6 months, Patients who are not already taking oral sodium bicarbonate, Able and willing to provide written informed consent

Exclusion Criteria:

Patients who primarily have predialysis potassium levels of less than 4mmols/L over the last 6 months, Patients who are already taking oral sodium bicarbonate, Patients on lithium, Bedbound patients, Pregnant patients, Dementia, Recurrent hospital admissions, Non-English speaking and unable to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment

Standard haemodialysis treatment thrice weekly (using a standard dialysate containing bicarbonate at a concentration of 35mmols/L) with the addition of oral sodium bicarbonate 500mg capsules for 12 weeks (weeks 5-16 of the study).

The dosage will be titrated to individual blood levels. Starting dose will be 1g twice daily and if predialysis bicarbonate levels remain <22mmols/L the dose will be increased by 0.5g twice daily each week. The maximum dose would be 3g twice daily.

The oral sodium bicarbonate may be withheld on dialysis days, when bicarbonate will be supplemented through the dialysate. This will be assessed on a case by case basis.
Drug: sodium bicarbonate 500mg capsules
Defined by active substance and brand names not specified in protocol
No Intervention: Control
Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre dialysis potassium level and intradialytic potassium gradient
Time Frame: 12 weekly blood tests over a period of 16 weeks
Measurements over the first 4 weeks to establish blood potassium profile. Measurements over weeks 5-8 to detect early blood changes. Measurement over weeks 13-16 to detect late blood changes.
12 weekly blood tests over a period of 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 lead Electrocardiogram analysis
Time Frame: 3 timepoints (weeks 4, 8 and 16) over a period of 16 weeks
Electrocardiogram analysis before and after dialysis for the measurement of QT dispersion. Increase of the QT dispersion is linked to risk of ventricular arrhythmias.
3 timepoints (weeks 4, 8 and 16) over a period of 16 weeks
Total body muscle mass
Time Frame: 2 timepoints (weeks 4 and 16) over a period of 16 weeks
Body composition measurement before dialysis with the validated body composition monitor by Fresenius
2 timepoints (weeks 4 and 16) over a period of 16 weeks
Handgrip strength
Time Frame: 2 timepoints (weeks 4 and 16) over a period of 16 weeks
Handgrip strength to measure muscle function. Measured before dialysis with the ®Jamar handgrip dynamometer.
2 timepoints (weeks 4 and 16) over a period of 16 weeks
Symptom severity
Time Frame: 3 timepoints (weeks 4,8 and 16) over a period of 16 weeks
Haemodialysis related symptoms measured by a validated palliative outcome symptom scale-renal questionnaire (POS-S)
3 timepoints (weeks 4,8 and 16) over a period of 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Damien Ashby, PhD, MRCP, Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15HH2613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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