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

End-stage Renal Disease Clinical Trial

— BicHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692378
• Other study ID #: 15HH2613
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2016
• Last updated: September 30, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2015
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• sodium bicarbonate 500mg capsules
Defined by active substance and brand names not specified in protocol

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

Bleyer AJ, Russell GB, Satko SG. Sudden and cardiac death rates in hemodialysis patients. Kidney Int. 1999 Apr;55(4):1553-9. — View Citation

Bossola M, Giungi S, Tazza L, Luciani G. Long-term oral sodium bicarbonate supplementation does not improve serum albumin levels in hemodialysis patients. Nephron Clin Pract. 2007;106(1):c51-6. Epub 2007 Apr 2. — View Citation

Brady JP, Hasbargen JA. Correction of metabolic acidosis and its effect on albumin in chronic hemodialysis patients. Am J Kidney Dis. 1998 Jan;31(1):35-40. — View Citation

Brass EP, Adler S, Sietsema KE, Amato A, Esler A, Hiatt WR. Peripheral arterial disease is not associated with an increased prevalence of intradialytic cramps in patients on maintenance hemodialysis. Am J Nephrol. 2002 Sep-Dec;22(5-6):491-6. — View Citation

Cupisti A, Galetta F, Caprioli R, Morelli E, Tintori GC, Franzoni F, Lippi A, Meola M, Rindi P, Barsotti G. Potassium removal increases the QTc interval dispersion during hemodialysis. Nephron. 1999 Jun;82(2):122-6. — View Citation

Graham KA, Reaich D, Channon SM, Downie S, Goodship TH. Correction of acidosis in hemodialysis decreases whole-body protein degradation. J Am Soc Nephrol. 1997 Apr;8(4):632-7. — View Citation

Heguilén RM, Sciurano C, Bellusci AD, Fried P, Mittelman G, Rosa Diez G, Bernasconi AR. The faster potassium-lowering effect of high dialysate bicarbonate concentrations in chronic haemodialysis patients. Nephrol Dial Transplant. 2005 Mar;20(3):591-7. Epub 2005 Feb 1. — View Citation

Ikizler TA, Pupim LB, Brouillette JR, Levenhagen DK, Farmer K, Hakim RM, Flakoll PJ. Hemodialysis stimulates muscle and whole body protein loss and alters substrate oxidation. Am J Physiol Endocrinol Metab. 2002 Jan;282(1):E107-16. — View Citation

Movilli E, Viola BF, Camerini C, Mazzola G, Cancarini GC. Correction of metabolic acidosis on serum albumin and protein catabolism in hemodialysis patients. J Ren Nutr. 2009 Mar;19(2):172-7. doi: 10.1053/j.jrn.2008.08.012. — View Citation

Vashistha T, Kalantar-Zadeh K, Molnar MZ, Torlén K, Mehrotra R. Dialysis modality and correction of uremic metabolic acidosis: relationship with all-cause and cause-specific mortality. Clin J Am Soc Nephrol. 2013 Feb;8(2):254-64. doi: 10.2215/CJN.05780612. Epub 2012 Nov 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre dialysis potassium level and intradialytic potassium gradient	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	No
Secondary	12 lead Electrocardiogram analysis	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	No
Secondary	Total body muscle mass	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	No
Secondary	Handgrip strength	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	No
Secondary	Symptom severity	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	No

External Links

•   Sodium bicarbonate 500mg capsules Summary of Product Characteristics