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

NCT02692378 | Completed Phase 4 DMC

• 1 other identifier: 15HH2613
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-stage Renal Disease

Keywords

Haemodialysis; sodium bicarbonate; potassium; arrhythmia; muscle; symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 12 lead Electrocardiogram analysis

  3 timepoints (weeks 4, 8 and 16) over a period of 16 weeks

• Total body muscle mass

  2 timepoints (weeks 4 and 16) over a period of 16 weeks

• Handgrip strength

  2 timepoints (weeks 4 and 16) over a period of 16 weeks

• Symptom severity

  3 timepoints (weeks 4,8 and 16) over a period of 16 weeks

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L.

Interventions

sodium bicarbonate 500mg capsules DRUG

Defined by active substance and brand names not specified in protocol

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 10201022 BACKGROUND

• 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.

  PMID: 17409769 BACKGROUND

• 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.

  PMID: 9428449 BACKGROUND

• 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.

  PMID: 12381949 BACKGROUND

• 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.

  PMID: 10364703 BACKGROUND

• 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.

  PMID: 10495793 BACKGROUND

• 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.

  PMID: 15687112 BACKGROUND

• 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.

  PMID: 11739090 BACKGROUND

• 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.

  PMID: 19218045 BACKGROUND

• 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.

  PMID: 23184567 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Arrhythmias, Cardiac

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Damien Ashby, PhD, MRCP

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 3, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)