The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension

NCT02719223 | Completed

• 1 other identifier: 0002-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale and objectives

1. 1.Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis (HD). The investigator will follow the hemodynamic parameters during the dialysis sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.
2. 2.By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate the hemodynamic parameters and compare the two renal replacement treatment modalities, and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.

Conditions

Intradialytic Hypotension

Keywords

Intradialytic hypotension; hemodynamic parameters; Hemodiafiltration; NICAS device (non-invasive cardiac system)

Outcome Measures

Primary Outcomes (4)

• The superiority of OL-HDF over regular hemodialysis in decreasing the frequency of intradialytic hypertension episodes.

  5 weeks

• Mean arterial pressure (mm/Hg)

  5 weeks

• Cardiac index (l/min/m2)

  5 weeks

• Total peripheral resistance (dynes/sec/cm5)

  5 weeks

Study Arms (2)

High Flux Hemodialysis

EXPERIMENTAL

Device: NICaS

OL-HDF

EXPERIMENTAL

Device: NICaS

Interventions

NICaS DEVICE

The NICaS is a non invasive device for measuring and calculating of hemodynamic parameters including mean arterial pressure (mm/Hg), cardiac index (l/min/m2) and total peripheral resistance (dynes/sec/cm5).

High Flux Hemodialysis; OL-HDF

Eligibility Criteria

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

You may qualify if:

• Patients affected by IDH during one or more dialytic sessions every week

You may not qualify if:

• Patients with recent change in chronic medications, chronic liver disease, recent acute coronary event, cardiac arrhythmias and acute infection.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Related Publications (14)

• Daugirdas JT. Pathophysiology of dialysis hypotension: an update. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S11-7. doi: 10.1053/ajkd.2001.28090.

  PMID: 11602456 RESULT

• K/DOQI Workgroup. K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153. No abstract available.

  PMID: 15806502 RESULT

• Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.

  PMID: 12490682 RESULT

• 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.

  PMID: 21803971 RESULT

• 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. doi: 10.1046/j.1523-1755.2000.00229.x.

  PMID: 10916105 RESULT

• 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. doi: 10.1111/j.1523-1755.2004.00812.x.

  PMID: 15327420 RESULT

• Zoccali C, Benedetto FA, Tripepi G, Mallamaci F. Cardiac consequences of hypertension in hemodialysis patients. Semin Dial. 2004 Jul-Aug;17(4):299-303. doi: 10.1111/j.0894-0959.2004.17331.x.

  PMID: 15250922 RESULT

• Caplin B, Kumar S, Davenport A. Patients' perspective of haemodialysis-associated symptoms. Nephrol Dial Transplant. 2011 Aug;26(8):2656-63. doi: 10.1093/ndt/gfq763. Epub 2011 Jan 6.

  PMID: 21212166 RESULT

• Sands JJ, Usvyat LA, Sullivan T, Segal JH, Zabetakis P, Kotanko P, Maddux FW, Diaz-Buxo JA. Intradialytic hypotension: frequency, sources of variation and correlation with clinical outcome. Hemodial Int. 2014 Apr;18(2):415-22. doi: 10.1111/hdi.12138. Epub 2014 Jan 27.

  PMID: 24467830 RESULT

• 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 RESULT

• Ewing DJ, Winney R. Autonomic function in patients with chronic renal failure on intermittent haemodialysis. Nephron. 1975;15(6):424-9. doi: 10.1159/000180525.

  PMID: 1196462 RESULT

• Lilley JJ, Golden J, Stone RA. Adrenergic regulation of blood pressure in chronic renal failure. J Clin Invest. 1976 May;57(5):1190-200. doi: 10.1172/JCI108387.

  PMID: 1262465 RESULT

• Daugirdas JT. Dialysis hypotension: a hemodynamic analysis. Kidney Int. 1991 Feb;39(2):233-46. doi: 10.1038/ki.1991.28. No abstract available.

  PMID: 2002637 RESULT

• Santoro A. Cardiovascular dialysis instability and convective therapies. Hemodial Int. 2006 Jan;10 Suppl 1:S51-5. doi: 10.1111/j.1542-4758.2006.01192.x.

  PMID: 16441871 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2016
• First Posted: March 25, 2016
• Study Start: January 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

IL (1)