End Stage Renal Disease on Dialysis Clinical Trial
— TURBOOfficial title:
Hemodynamic Effects of Low vs. High Dialysate Temperature or Bicarbonate Concentration in Chronic Hemodialysis Patients
Verified date | August 2021 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To elucidate the role of dialysate temperature and bicarbonate on hemodynamic parameters, plasma pH and electrolytes that potentially mediate this effect, the investigators wish to conduct a single-blinded, randomized, controlled, crossover study, specifically examining the effects of - A fixed low temperature dialysate of 35°C compared to a fixed dialysate temperature of 37°C. - A low dialysate bicarbonate concentration of 30 mmol/L compared to a high dialysate bicarbonate concentration of 38 mmol/L.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 3, 2022 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Regular dialysis (HD or HDF) therapy for >3 months - Age >18 years - Stable and functional arteriovenous (AV)-fistula - Able to achieve a dialysis blood flow > 250 mL - Able to stand up for a minimum of 10 min - Able to undergo a 4 hour dialysis session without eating, drinking or sleeping - Proven cabable of cumulative ultrafiltration of 2% of end-dialytic weight (EDW) - Able to give informed consent to participation in the study - Hematocrit >30% - BMI >18 and <35 Exclusion Criteria: - Central venous catheter for HD or HDF - Recirculation in AV-fistula - Acute myocardial infarction within 3 months - Atrial fibrillation - Active malignant or infectious diseases - Cerebrovascular incident within 3 months - Pregnancy - Alcohol or drug abuse - History of interruptions during HD or untimely termination of HD treatment |
Country | Name | City | State |
---|---|---|---|
Denmark | Dialysis Clinic at Department of Renal Medicine, Aarhus University Hospital and affiliated dialysis clinics in Randers and Horsens | Aarhus | Region Midt |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Ayoub A, Finlayson M. Effect of cool temperature dialysate on the quality and patients' perception of haemodialysis. Nephrol Dial Transplant. 2004 Jan;19(1):190-4. — View Citation
Beerenhout C, Dejagere T, van der Sande FM, Bekers O, Leunissen KM, Kooman JP. Haemodynamics and electrolyte balance: a comparison between on-line pre-dilution haemofiltration and haemodialysis. Nephrol Dial Transplant. 2004 Sep;19(9):2354-9. Epub 2004 Jul 20. — View Citation
Chang TI, Paik J, Greene T, Desai M, Bech F, Cheung AK, Chertow GM. Intradialytic hypotension and vascular access thrombosis. J Am Soc Nephrol. 2011 Aug;22(8):1526-33. doi: 10.1681/ASN.2010101119. — View Citation
Chesterton LJ, Selby NM, Burton JO, McIntyre CW. Cool dialysate reduces asymptomatic intradialytic hypotension and increases baroreflex variability. Hemodial Int. 2009 Apr;13(2):189-96. doi: 10.1111/j.1542-4758.2009.00355.x. — View Citation
Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13. — View Citation
Elsharkawy MM, Youssef AM, Zayoon MY. Intradialytic changes of serum magnesium and their relation to hypotensive episodes in hemodialysis patients on different dialysates. Hemodial Int. 2006 Oct;10 Suppl 2:S16-23. — View Citation
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. — View Citation
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. — View Citation
Gabutti L, Ross V, Duchini F, Mombelli G, Marone C. Does bicarbonate transfer have relevant hemodynamic consequences in standard hemodialysis? Blood Purif. 2005;23(5):365-72. Epub 2005 Jul 27. — View Citation
Gabutti L, Salvadé 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. — 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
Hoeben H, Abu-Alfa AK, Mahnensmith R, Perazella MA. Hemodynamics in patients with intradialytic hypotension treated with cool dialysate or midodrine. Am J Kidney Dis. 2002 Jan;39(1):102-7. — View Citation
Jost CM, Agarwal R, Khair-el-Din T, Grayburn PA, Victor RG, Henrich WL. Effects of cooler temperature dialysate on hemodynamic stability in "problem" dialysis patients. Kidney Int. 1993 Sep;44(3):606-12. — View Citation
Karamperis N, Sloth E, Jensen JD. The hemodynamic effect of calcium ion concentration in the infusate during predilution hemofiltration in chronic renal failure. Am J Kidney Dis. 2005 Sep;46(3):470-80. — View Citation
Kaufman AM, Morris AT, Lavarias VA, Wang Y, Leung JF, Glabman MB, Yusuf SA, Levoci AL, Polaschegg HD, Levin NW. Effects of controlled blood cooling on hemodynamic stability and urea kinetics during high-efficiency hemodialysis. J Am Soc Nephrol. 1998 May;9(5):877-83. — View Citation
Kisloukhine VV, Dean DA. Validation of a novel ultrasound dilution method to measure cardiac output during hemodialysis. ASAIO J. 1996 Sep-Oct;42(5):M906-7. — View Citation
Kooman J, Basci A, Pizzarelli F, Canaud B, Haage P, Fouque D, Konner K, Martin-Malo A, Pedrini L, Tattersall J, Tordoir J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG guideline on haemodynamic instability. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii22-44. — View Citation
Krivitski NM, Depner TA. Cardiac output and central blood volume during hemodialysis: methodology. Adv Ren Replace Ther. 1999 Jul;6(3):225-32. — View Citation
Kuipers J, Verboom LM, Ipema KJR, Paans W, Krijnen WP, Gaillard CAJM, Westerhuis R, Franssen CFM. The Prevalence of Intradialytic Hypotension in Patients on Conventional Hemodialysis: A Systematic Review with Meta-Analysis. Am J Nephrol. 2019;49(6):497-506. doi: 10.1159/000500877. Epub 2019 May 24. — View Citation
Kyriazis J, Glotsos J, Bilirakis L, Smirnioudis N, Tripolitou M, Georgiakodis F, Grimani I. Dialysate calcium profiling during hemodialysis: use and clinical implications. Kidney Int. 2002 Jan;61(1):276-87. — View Citation
Kyriazis J, Kalogeropoulou K, Bilirakis L, Smirnioudis N, Pikounis V, Stamatiadis D, Liolia E. Dialysate magnesium level and blood pressure. Kidney Int. 2004 Sep;66(3):1221-31. — View Citation
Moser M, Kenner T. Blood flow and blood volume determinations in aorta and in coronary circulation by density dilution. Basic Res Cardiol. 1988 Nov-Dec;83(6):577-89. — View Citation
Pakfetrat M, Roozbeh Shahroodi J, Malekmakan L, Zare N, Hashemi Nasab M, Hossein Nikoo M. Is there an association between intradialytic hypotension and serum magnesium changes? Hemodial Int. 2010 Oct;14(4):492-7. doi: 10.1111/j.1542-4758.2010.00477.x. — View Citation
Ronco C, Brendolan A, Milan M, Rodeghiero MP, Zanella M, La Greca G. Impact of biofeedback-induced cardiovascular stability on hemodialysis tolerance and efficiency. Kidney Int. 2000 Aug;58(2):800-8. — View Citation
Sajadi M, Gholami Z, Hekmatpou D, Soltani P, Haghverdi F. Cold Dialysis Solution for Hemodialysis Patients With Fatigue: a Cross-over Study. Iran J Kidney Dis. 2016 Sep;10(5):319-324. Erratum in: Iran J Kidney Dis. 2016 Nov;10 (6):419. — View Citation
Sasaki O, Nakahama H, Nakamura S, Yoshihara F, Inenaga T, Yoshii M, Kohno S, Kawano Y. Orthostatic hypotension at the introductory phase of haemodialysis predicts all-cause mortality. Nephrol Dial Transplant. 2005 Feb;20(2):377-81. Epub 2004 Dec 23. — View Citation
Selby NM, Burton JO, Chesterton LJ, McIntyre CW. Dialysis-induced regional left ventricular dysfunction is ameliorated by cooling the dialysate. Clin J Am Soc Nephrol. 2006 Nov;1(6):1216-25. Epub 2006 Oct 11. — View Citation
Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. — View Citation
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. — View Citation
Tislér A, Akócsi K, Borbás B, Fazakas L, Ferenczi S, Görögh S, Kulcsár I, Nagy L, Sámik J, Szegedi J, Tóth E, Wágner G, Kiss I. The effect of frequent or occasional dialysis-associated hypotension on survival of patients on maintenance haemodialysis. Nephrol Dial Transplant. 2003 Dec;18(12):2601-5. — View Citation
Tsutsui M, Matsuoka N, Ikeda T, Sanjo Y, Kazama T. Comparison of a new cardiac output ultrasound dilution method with thermodilution technique in adult patients under general anesthesia. J Cardiothorac Vasc Anesth. 2009 Dec;23(6):835-40. doi: 10.1053/j.jvca.2009.03.007. Epub 2009 May 22. — View Citation
van der Sande FM, Wystrychowski G, Kooman JP, Rosales L, Raimann J, Kotanko P, Carter M, Chan CT, Leunissen KM, Levin NW. Control of core temperature and blood pressure stability during hemodialysis. Clin J Am Soc Nephrol. 2009 Jan;4(1):93-8. doi: 10.2215/CJN.01800408. Epub 2008 Oct 8. — View Citation
Viegas M, Cândido C, Felgueiras J, Clemente J, Barros S, Farbota R, Vera F, Matos A, Sousa F. Dialysate bicarbonate variation in maintenance hemodiafiltration patients: Impact on serum bicarbonate, intradialytic hypotension and interdialytic weight gain. Hemodial Int. 2017 Jul;21(3):385-392. doi: 10.1111/hdi.12502. Epub 2016 Oct 20. — View Citation
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group . 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. Erratum in: Eur Heart J. 2019 Feb 1;40(5):475. — View Citation
Yu AW, Ing TS, Zabaneh RI, Daugirdas JT. Effect of dialysate temperature on central hemodynamics and urea kinetics. Kidney Int. 1995 Jul;48(1):237-43. — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood pressure (BP) | SBP (mmHg), Mean BP (mmHg) and Ortostatic BP (mmHg) | 4 weeks | |
Secondary | Intradialytic cardiac output | CO (L/min) | 4 weeks | |
Secondary | Intradialytic total peripheral resistance | TPR (mmHg/(L/min)) | 4 weeks | |
Secondary | Intradialytic stroke volume | SV (mL) | 4 weeks | |
Secondary | Intradialytic heart rate | HR (beats/min) | 4 weeks | |
Secondary | Intradialytic central blood volume | CBV (L) | 4 weeks | |
Secondary | Intradialytic mean arterial blood pressure | MAP (mmHg) | 4 weeks | |
Secondary | Plasma calcium | Calcium (mmol/L) | 4 weeks | |
Secondary | Plasma potassium | Potassium (mmol/L) | 4 weeks | |
Secondary | Plasma magnesium | Magnesium (mmol/L) | 4 weeks | |
Secondary | Intradialytic hypotension (IDH) | IDH frequency (number of events) | 4 weeks | |
Secondary | Ortostatic hypotension (OH) | OH frequency (number of events) | 4 weeks |
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