Potassium Kinetic During and After Hemodialysis and Potassium Profiling to Prevent Arrhythmias

NCT04563091 | Unknown DMC

• 1 other identifier: 38/2017/U/Sper
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is the development of a mathematical model for predicting potassium kinetics during and after the dialytic session. The secondary objectives of the study are:

1. 1.the definition of a correlation between the kinetics of intra and extra-cellular concentrations of potassium during and after the dialytic session and the onset of arrhythmias;
2. 2.the use of the mathematical model to modify the blood concentration of potassium by acting on the composition of the dialysis bath in order to minimize the risk of onset of arrhythmias during and after dialysis.

Conditions

Hemodialysis Complication; Arrhythmias; Potassium Imbalance

Outcome Measures

Primary Outcomes (1)

• Kinetics of intra and extra-cellular concentrations of potassium during and after the dialytic session

  This outcome is characterized by the measurements of intra and extracellular potassium. During dialysis starting at 8:00 a.m., measurements will be taken every 30 minutes. After 60 minutes of the end of dialysis, hourly measurements of intra-and extracellular potassium will be repeated.

  The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.

Secondary Outcomes (7)

• Kinetics of urea during and after the dialytic session

  The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.

• Kinetics of bicarbonates during and after the dialytic session

  The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.

• Kinetics of blood sugar during and after the dialytic session

  The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.

• Kinetics of sodium during and after the dialytic session

  The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.

• Sodium behaviour during dialysis

  The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.

Study Arms (1)

Interventional group

EXPERIMENTAL

The study population will consist of 6 evaluable, outpatient patients with chronic kidney failure who need to perform hemodialysis thrice weekly for their survival. In the case of drop out of a patient will be enrolled another patient to arrive at 6 patients evaluable both at the end of Period A and at the end of Period B of the study

Device: Hemodialysis with online HFR

Interventions

Hemodialysis with online HFR DEVICE

1. Hemodialytic therapy using 240-minute online HFR on Flexya® hemodialysis machine (Medtronic, Mirandola, Italy). The blood flow from vascular access will be maintained at values \> 250 ml/minute, the flow of dialysis fluid will be 500 ml/minute. Weight loss during dialytic treatment will be prescribed according to the patient's clinical needs. 2. Assess potassium (intra and extra cellular), sodium, bicarbonatemia, calcemia, urea, blood sugar values and ECG every 30 minutes during dialysis and every 60 minutes after dialysis. 3. Body impedance analysis at time 0 at 240 minutes, after 60 minutes after the end of dialysis and after 7 hours after the end of dialysis. 4. Use of the Natrium sensor (Medtronic, Mirandola, Italy) during HFR dialytic treatment.

Also known as: Blood samples, Body impedance analysis, Electrocardiograms, Use of Natrium sensor

Interventional group

Eligibility Criteria

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

You may qualify if:

• end stage renal failure on chronic hemodialysis
• thrice weekly hemodialysis;
• urine output \< 100 ml/day;
• low potassium diet (max 2 gr/day);
• Age \> 18 years;
• Arterovenous fistula for hemodialysis with blood flow \> 250 ml/min;
• Written informed consent to participate.

You may not qualify if:

• Intradialytic hypotension: 30% of dialysis sessions during the last month before enrollment with intradialytic systolic blood pressure reduction \> 25 mmHg;
• Need of intradialytic potassium administration;
• Antiarrythmic drugs prescription;
• Recent myocardial infarction;
• Fever;
• Anemia (Hb \< 8 gr%);
• Enteritis.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator

Study Sites (1)

Nephrology Dialysis and Renal Transplantation Unit, St.Orsola University Hospital

Bologna, 40138, Italy

RECRUITING

Related Publications (26)

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  PMID: 22403271 BACKGROUND

• Hung AM, Hakim RM. Dialysate and serum potassium in hemodialysis. Am J Kidney Dis. 2015 Jul;66(1):125-32. doi: 10.1053/j.ajkd.2015.02.322. Epub 2015 Mar 28.

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• Shapira OM, Bar-Khayim Y. ECG changes and cardiac arrhythmias in chronic renal failure patients on hemodialysis. J Electrocardiol. 1992 Oct;25(4):273-9. doi: 10.1016/0022-0736(92)90032-u.

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• Gussak I, Gussak HM. Sudden cardiac death in nephrology: focus on acquired long QT syndrome. Nephrol Dial Transplant. 2007 Jan;22(1):12-4. doi: 10.1093/ndt/gfl587. Epub 2006 Nov 8. No abstract available.

  PMID: 17093009 BACKGROUND

• Bignotto LH, Kallas ME, Djouki RJ, Sassaki MM, Voss GO, Soto CL, Frattini F, Medeiros FS. Electrocardiographic findings in chronic hemodialysis patients. J Bras Nefrol. 2012 Jul-Sep;34(3):235-42. doi: 10.5935/0101-2800.20120004.

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• Foley RN, Gilbertson DT, Murray T, Collins AJ. Long interdialytic interval and mortality among patients receiving hemodialysis. N Engl J Med. 2011 Sep 22;365(12):1099-107. doi: 10.1056/NEJMoa1103313.

  PMID: 21992122 BACKGROUND

• Bleyer AJ, Hartman J, Brannon PC, Reeves-Daniel A, Satko SG, Russell G. Characteristics of sudden death in hemodialysis patients. Kidney Int. 2006 Jun;69(12):2268-73. doi: 10.1038/sj.ki.5000446. Epub 2006 May 3.

  PMID: 16672908 BACKGROUND

• Genovesi S, Dossi C, Vigano MR, Galbiati E, Prolo F, Stella A, Stramba-Badiale M. Electrolyte concentration during haemodialysis and QT interval prolongation in uraemic patients. Europace. 2008 Jun;10(6):771-7. doi: 10.1093/europace/eun028. Epub 2008 Feb 19.

  PMID: 18287086 BACKGROUND

• Pun PH, Lehrich RW, Honeycutt EF, Herzog CA, Middleton JP. Modifiable risk factors associated with sudden cardiac arrest within hemodialysis clinics. Kidney Int. 2011 Jan;79(2):218-27. doi: 10.1038/ki.2010.315. Epub 2010 Sep 1.

  PMID: 20811332 BACKGROUND

• Kovesdy CP, Regidor DL, Mehrotra R, Jing J, McAllister CJ, Greenland S, Kopple JD, Kalantar-Zadeh K. Serum and dialysate potassium concentrations and survival in hemodialysis patients. Clin J Am Soc Nephrol. 2007 Sep;2(5):999-1007. doi: 10.2215/CJN.04451206. Epub 2007 Aug 16.

  PMID: 17702709 BACKGROUND

• Karnik JA, Young BS, Lew NL, Herget M, Dubinsky C, Lazarus JM, Chertow GM. Cardiac arrest and sudden death in dialysis units. Kidney Int. 2001 Jul;60(1):350-7. doi: 10.1046/j.1523-1755.2001.00806.x.

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• Pani A, Floris M, Rosner MH, Ronco C. Hyperkalemia in hemodialysis patients. Semin Dial. 2014 Nov-Dec;27(6):571-6. doi: 10.1111/sdi.12272. Epub 2014 Jul 8.

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  PMID: 9719202 BACKGROUND

• Blumberg A, Roser HW, Zehnder C, Muller-Brand J. Plasma potassium in patients with terminal renal failure during and after haemodialysis; relationship with dialytic potassium removal and total body potassium. Nephrol Dial Transplant. 1997 Aug;12(8):1629-34. doi: 10.1093/ndt/12.8.1629.

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• Rombola G, Colussi G, De Ferrari ME, Frontini A, Minetti L. Cardiac arrhythmias and electrolyte changes during haemodialysis. Nephrol Dial Transplant. 1992;7(4):318-22. doi: 10.1093/oxfordjournals.ndt.a092135.

  PMID: 1317522 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

• Tentori F, Karaboyas A, Robinson BM, Morgenstern H, Zhang J, Sen A, Ikizler TA, Rayner H, Fissell RB, Vanholder R, Tomo T, Port FK. Association of dialysate bicarbonate concentration with mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2013 Oct;62(4):738-46. doi: 10.1053/j.ajkd.2013.03.035. Epub 2013 May 24.

  PMID: 23707043 BACKGROUND

• Nicola L, Bellizzi V, Minutolo R, Cioffi M, Giannattasio P, Terracciano V, Iodice C, Uccello F, Memoli B, Iorio BRD, Conte G. Effect of dialysate sodium concentration on interdialytic increase of potassium. J Am Soc Nephrol. 2000 Dec;11(12):2337-2343. doi: 10.1681/ASN.V11122337.

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• Basile C, Libutti P, Lisi P, Teutonico A, Vernaglione L, Casucci F, Lomonte C. Ranking of factors determining potassium mass balance in bicarbonate haemodialysis. Nephrol Dial Transplant. 2015 Mar;30(3):505-13. doi: 10.1093/ndt/gfu376. Epub 2014 Dec 13.

  PMID: 25500805 BACKGROUND

• Ursino M, Coli L, Dalmastri V, Volpe F, La Manna G, Avanzolini G, Stefoni S, Bonomini V. An algorithm for the rational choice of sodium profile during hemodialysis. Int J Artif Organs. 1997 Dec;20(12):659-72.

  PMID: 9506779 BACKGROUND

• Coli L, Ursino M, Dalmastri V, Volpe F, La Manna G, Avanzolini G, Stefoni S, Bonomini V. A simple mathematical model applied to selection of the sodium profile during profiled haemodialysis. Nephrol Dial Transplant. 1998 Feb;13(2):404-16.

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MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Renal Dialysis; Blood Specimen Collection; Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Central Study Contacts

Gaetano La Manna, Prof.

CONTACT

+300512144577; gaetano.lamanna@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 24, 2020
• Study Start: November 15, 2018
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2025
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

IT (1)