Effects of Oral Sodium Bicarbonate Supplementation in Haemodialysis Patients (BicHD)
NCT ID: NCT02692378
Last Updated: 2016-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2015-11-30
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
sodium bicarbonate 500mg capsules
Defined by active substance and brand names not specified in protocol
Control
Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L.
No interventions assigned to this group
Interventions
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sodium bicarbonate 500mg capsules
Defined by active substance and brand names not specified in protocol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Damien Ashby, PhD, MRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College Healthcare NHS Trust
Locations
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Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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References
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Bleyer AJ, Russell GB, Satko SG. Sudden and cardiac death rates in hemodialysis patients. Kidney Int. 1999 Apr;55(4):1553-9. doi: 10.1046/j.1523-1755.1999.00391.x.
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. doi: 10.1159/000101484. Epub 2007 Apr 2.
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. doi: 10.1053/ajkd.1998.v31.pm9428449.
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. doi: 10.1159/000065285.
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. doi: 10.1159/000045387.
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. doi: 10.1681/ASN.V84632.
Heguilen 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. doi: 10.1093/ndt/gfh661. Epub 2005 Feb 1.
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. doi: 10.1152/ajpendo.2002.282.1.E107.
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.
Vashistha T, Kalantar-Zadeh K, Molnar MZ, Torlen 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.
Other Identifiers
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15HH2613
Identifier Type: -
Identifier Source: org_study_id
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