Potassium in Haemodialysis Fluids and Haemodynamics

NCT01224314 | Completed

• 1 other identifier: 010010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

In a study published in 1995 in the American Journal of Kidney Diseases, Dolson et al demonstrated that a rapid decrease of serum potassium concentrations during haemodialysis would produce a significant increase in systolic blood pressure at the end of the session, even though there were no clear effects on intra-dialytic blood pressure. The authors defined this post-dialysis blood pressure behaviour as "rebound hypertension". Paradoxically, in animal models, other than in the context of end-stage renal disease, potassium is a vasodilator. Considering that the removal of potassium during the haemodialysis session could be theoretically modulated in profiles (as with sodium and bicarbonate), it was deemed suitable to delve deeper into this argument by studying, in detail, the (non invasive) hemodynamic repercussions of changes in the potassium concentration of the dialysate. Not being able to linearly modify the concentration, we decided to divide the dialysis session in 3 tertiles, randomising the patients to all possible dialysate sequences containing the usual concentration of potassium or two cut-off points at +1 and -1 mmol/l. Haemodynamic measurements were performed using a finger beat-to-beat monitor.

Conditions

Haemodialysis

Keywords

Haemodynamics; Hypotension; Potassium; Haemodialysis; Dialysis fluids

Outcome Measures

Primary Outcomes (1)

• haemodynamic consequences of dialysate potassium concentration

  difference in haemodynamic parameters between the extremes in potassium concentration of the dialysate

  4 weeks

Secondary Outcomes (1)

• incidence of hypotension

  4 weeks

Study Arms (2)

dialysis fluid potassium high

ACTIVE COMPARATOR

potassium concentration in the dialysis fluid 1 mmol/L higher than usual

Other: Changing potassium concentration in dialysis fluids

dialysis fluid potassium low

ACTIVE COMPARATOR

potassium concentration in the dialysis fluid 1 mmol/L lower than usual

Other: Changing potassium concentration in dialysis fluids

Interventions

Changing potassium concentration in dialysis fluids OTHER

The dialysis sessions was divided into 3 tertiles, casually modulating potassium concentration in the dialysate between the value normally used K and the two cut-off points K+1 and K-1 mmol/l

Also known as: Potassium concentrations in haemodialysis fluids

dialysis fluid potassium high; dialysis fluid potassium low

Eligibility Criteria

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

You may qualify if:

• chronic haemodialysis patients
• dialysed 3 to 4 hours three times a week
• clinically stable and without intercurrent illnesses

You may not qualify if:

• intercurrent illnesses

Sponsors & Collaborators

• Ospedale Regionale di Locarno: lead
• Fondazione Ettore Balli Locarno: collaborator

Study Sites (1)

Ospedale Regionale di Locarno

Locarno, Canton Ticino, 6600, Switzerland

Location

Related Publications (24)

• Dolson GM, Ellis KJ, Bernardo MV, Prakash R, Adrogue HJ. Acute decreases in serum potassium augment blood pressure. Am J Kidney Dis. 1995 Aug;26(2):321-6. doi: 10.1016/0272-6386(95)90652-5.

  PMID: 7645536 BACKGROUND

• Rastegar A, Soleimani M. Hypokalaemia and hyperkalaemia. Postgrad Med J. 2001 Dec;77(914):759-64. doi: 10.1136/pmj.77.914.759.

  PMID: 11723313 BACKGROUND

• Bia MJ, DeFronzo RA. Extrarenal potassium homeostasis. Am J Physiol. 1981 Apr;240(4):F257-68. doi: 10.1152/ajprenal.1981.240.4.F257.

  PMID: 6111930 BACKGROUND

• Fernandez J, Oster JR, Perez GO. Impaired extrarenal disposal of an acute oral potassium load in patients with endstage renal disease on chronic hemodialysis. Miner Electrolyte Metab. 1986;12(2):125-9.

  PMID: 3960016 BACKGROUND

• Perez GO, Pelleya R, Oster JR, Kem DC, Vaamonde CA. Blunted kaliuresis after an acute potassium load in patients with chronic renal failure. Kidney Int. 1983 Nov;24(5):656-62. doi: 10.1038/ki.1983.208.

  PMID: 6663988 BACKGROUND

• Musso CG. Potassium metabolism in patients with chronic kidney disease. Part II: patients on dialysis (stage 5). Int Urol Nephrol. 2004;36(3):469-72. doi: 10.1007/s11255-004-6194-y.

  PMID: 15783126 BACKGROUND

• Locatelli F, Covic A, Chazot C, Leunissen K, Luno J, Yaqoob M. Optimal composition of the dialysate, with emphasis on its influence on blood pressure. Nephrol Dial Transplant. 2004 Apr;19(4):785-96. doi: 10.1093/ndt/gfh102.

  PMID: 15031331 BACKGROUND

• Morris RC Jr, Sebastian A, Forman A, Tanaka M, Schmidlin O. Normotensive salt sensitivity: effects of race and dietary potassium. Hypertension. 1999 Jan;33(1):18-23. doi: 10.1161/01.hyp.33.1.18.

  PMID: 9931076 BACKGROUND

• Stamler J, Rose G, Elliott P, Dyer A, Marmot M, Kesteloot H, Stamler R. Findings of the International Cooperative INTERSALT Study. Hypertension. 1991 Jan;17(1 Suppl):I9-15. doi: 10.1161/01.hyp.17.1_suppl.i9.

  PMID: 1987018 BACKGROUND

• Whelton PK, He J, Cutler JA, Brancati FL, Appel LJ, Follmann D, Klag MJ. Effects of oral potassium on blood pressure. Meta-analysis of randomized controlled clinical trials. JAMA. 1997 May 28;277(20):1624-32. doi: 10.1001/jama.1997.03540440058033.

  PMID: 9168293 BACKGROUND

• Amberg GC, Bonev AD, Rossow CF, Nelson MT, Santana LF. Modulation of the molecular composition of large conductance, Ca(2+) activated K(+) channels in vascular smooth muscle during hypertension. J Clin Invest. 2003 Sep;112(5):717-24. doi: 10.1172/JCI18684.

  PMID: 12952920 BACKGROUND

• Haddy FJ, Vanhoutte PM, Feletou M. Role of potassium in regulating blood flow and blood pressure. Am J Physiol Regul Integr Comp Physiol. 2006 Mar;290(3):R546-52. doi: 10.1152/ajpregu.00491.2005.

  PMID: 16467502 BACKGROUND

• Rodrigo F, Shideman J, McHugh R, Buselmeier T, Kjellstrand C. Osmolality changes during hemodialysis. Natural history, clinical correlations, and influence of dialysate glucose and intravenous mannitol. Ann Intern Med. 1977 May;86(5):554-61. doi: 10.7326/0003-4819-86-5-554.

  PMID: 851303 BACKGROUND

• van der Sande FM, Kooman JP, Leunissen KM. Intradialytic hypotension--new concepts on an old problem. Nephrol Dial Transplant. 2000 Nov;15(11):1746-8. doi: 10.1093/ndt/15.11.1746. No abstract available.

  PMID: 11071958 BACKGROUND

• Gabutti L, Bianchi G, Soldini D, Marone C, Burnier M. Haemodynamic consequences of changing bicarbonate and calcium concentrations in haemodialysis fluids. Nephrol Dial Transplant. 2009 Mar;24(3):973-81. doi: 10.1093/ndt/gfn541. Epub 2008 Oct 8.

  PMID: 18842671 BACKGROUND

• Gabutti L, Ferrari N, Giudici G, Mombelli G, Marone C. Unexpected haemodynamic instability associated with standard bicarbonate haemodialysis. Nephrol Dial Transplant. 2003 Nov;18(11):2369-76. doi: 10.1093/ndt/gfg383.

  PMID: 14551368 BACKGROUND

• Sulowicz W, Radziszewski A. Dialysis induced hypotension--a serious clinical problem in renal replacement therapy. Med Pregl. 2007;60 Suppl 2:14-20.

  PMID: 18928150 BACKGROUND

• Leunissen KM, Kooman JP, van Kuijk W, van der Sande F, Luik AJ, van Hooff JP. Preventing haemodynamic instability in patients at risk for intra-dialytic hypotension. Nephrol Dial Transplant. 1996;11 Suppl 2:11-5. doi: 10.1093/ndt/11.supp2.11.

  PMID: 8803987 BACKGROUND

• Selby NM, McIntyre CW. A systematic review of the clinical effects of reducing dialysate fluid temperature. Nephrol Dial Transplant. 2006 Jul;21(7):1883-98. doi: 10.1093/ndt/gfl126. Epub 2006 Apr 6.

  PMID: 16601075 BACKGROUND

• van Kuijk WH, Wirtz JJ, Grave W, de Heer F, Menheere PP, van Hooff JP, Leunissen KM. Vascular reactivity during combined ultrafiltration-haemodialysis: influence of dialysate sodium. Nephrol Dial Transplant. 1996 Feb;11(2):323-8. doi: 10.1093/oxfordjournals.ndt.a027261.

  PMID: 8671787 BACKGROUND

• Kim MJ, Song Jh, Kim Ga, Lim Hj, Lee Sw. Optimization of dialysate sodium in sodium profiling haemodialysis. Nephrology (Carlton). 2003 Oct;8 Suppl:S16-22. doi: 10.1046/j.1440-1797.8.s.2.x.

  PMID: 15012686 BACKGROUND

• Stefanidis I, Stiller S, Ikonomov V, Mann H. Sodium and body fluid homeostasis in profiling hemodialysis treatment. Int J Artif Organs. 2002 May;25(5):421-8. doi: 10.1177/039139880202500512.

  PMID: 12074340 BACKGROUND

• Stiller S, Bonnie-Schorn E, Grassmann A, Uhlenbusch-Korwer I, Mann H. A critical review of sodium profiling for hemodialysis. Semin Dial. 2001 Sep-Oct;14(5):337-47. doi: 10.1046/j.1525-139x.2001.00086.x.

  PMID: 11679103 BACKGROUND

• Gabutti L, Salvade I, Lucchini B, Soldini D, Burnier M. Haemodynamic consequences of changing potassium concentrations in haemodialysis fluids. BMC Nephrol. 2011 Apr 6;12:14. doi: 10.1186/1471-2369-12-14.

  PMID: 21470404 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Dialysis Solutions

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Luca Gabutti, MD

  Ospedale Regionale di Locarno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 20, 2010

Record last verified: 2007-08

Locations

CH (1)