End stage renal disease and metabolic acidosis with renal replacement therapy of haemodialysis.
Conditions
Interventions
Trade Name: Sodium Bicarbonate
Product Name: Sodium Bicarbonate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sodium bicarbonate
Sponsors
Imperial College Healthcare NHS Trust and Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients on haemodialysis for at least 3 months. 2. Aged between 18-80 years old (male and female) 3. Patients who primarily have predialysis bicarbonate levels of less than 22mmols/L (normal range is 22-26mmol/L) over the last 6 months. 4. No active infections or cancer diagnosis. 5. Able to give verbal and written informed consent. 6. Patients who are not already taking oral sodium bicarbonate. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1.Patients who primarily have predialysis potassium levels of less than 4mmols over the last 6 months. 2. Bedbound patients 3. Patients with a dementia diagnosis 4. Recurrent hospital admissions 5. Patients taking lithium medication (as this can be less well absorbed in the presence of sodium bicarbonate). 6. Non-English speaking and without access to a regular interpreter. 7. Patients lacking capacity and therefore unable to provide written informed consent 8. Pregnant patients 9. Patients who are already taking oral sodium bicarbonate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal research question: What are the effects of oral sodium bicarbonate supplementation in haemodialysis patients? Principal objective: Investigate the effect of oral sodium bicarbonate supplementation on blood potassium levels throughout the dialysis cycle (pre and post dialysis potassium and intradialysis potassium gradient). ; Secondary Objective: Secondary objectives: Investigate the effects of oral sodium bicarbonate supplementation on: 1. Risk of arrhythmia (i.e. abnormal heart rhythm) as measured by Electrocardiogram (ECG) analysis. 2. Muscle mass as measured by body composition monitoring. 3. Muscle function as measured by handgrip strength test. 4. Haemodialysis related cramps as measured by a symptom scale-renal questionnaire. ;Primary end point(s): The primary outcome measure is the predialysis blood potassium levels and intradialytic potassium gradient. ; Timepoint(s) of evaluation of this end point: The predialysis potassium levels will be measured throughout the study at weeks 1-8 and weeks 13-16. Total study duration is 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Electrocardiogram analysis with measurement of QT interval dispersion. 2. Body composition monitor to measure total body muscle mass. 3. Handgrip strength to measure muscle strength. 4. Symptom severity assessed with the use of a renal-scale symptom questionnaire to measure haemodialysis related cramps. ; Timepoint(s) of evaluation of this end point: 1. The electrocardiogram analysis will be done at baseline (week 4), middle of the study (weeks 8) and at the end of the study (week 16) 2. The body composition monitor will be done at baseline (week 4) and end of the study (week 16). 3. The handgrip strength test will be done at baseline (week 4) and end of the study (week 16). 4. The renal-scale symptom questionnaire will be done at baseline (week 4), middle of the study (week 8) and end of the study (week 16). | — |
Countries
United Kingdom
Contacts
Public ContactDr Damien Ashby
Imperial College Heathcare NHS Trust
Outcome results
None listed