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

Intradialytic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719223
• Other study ID #: 0002-16
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale and objectives

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. 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.

Description:

Intradialytic hypotension (IDH) or a significant fall in blood pressure (BP) is the most common complication that occurs during hemodialysis (HD) treatment, occurring in up to 20-33% of sessions.

Different mechanisms are involved in the pathogenesis of IDH including acute central hypovolemia, may be precipitated by rapid or excessive ultrafiltration that lead to intravascular volume depletion beyond the level of hemodynamic compensatory response. Other proposed mechanisms of intra vascular depletion are volume shift into the extra-vascular space due to rapid reduction in plasma osmolality, slow and incompatible vascular refilling rate and incorrectly low prescribed dry weight.

Autonomic dysfunction occurs in considerable amount of dialysis patients up to about 50% . This dysfunction reduces the ability to produce an adequate sympathetic response in the setting of acute volume diminution.

Due to the complexity of the dialysis treatment and absence of non- invasive technology, few studies followed the hemodynamic changes which occur during a dialysis session especially during IDH episodes.

OL- HDF is a relatively new method of therapy that allows a larger volume of blood filtration during a single dialysis therapy compared with standard hemodialysis.

Compared to conventional HD treatment, OL-HDF treatment was associated with lower incidence of IDH and better hemodynamic stability.

Bioelectrical impedance analysis is a method for estimating body composition in most of the cases. The Non-Invasive Cardiac System (NICaS) device (non-invasive cardiac system) applies the principle of Whole Body Bio-Impedance and provides continuous data regarding the hemodynamic status (i.e. heart rate, stroke volume, cardiac output, cardiac index, and total peripheral vascular resistance) as well as respiration rate and total body water.

Following the hemodynamic changes, the NICaS device will allow to shed light on the physiological mechanisms underlying the IDH phenomenon and prove the superiority of OL-HDF over regular hemodialysis regarding the hemodynamic measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hypotension
• Intradialytic Hypotension

Intervention

Device:
• NICaS
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).

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (14)

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. — 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

Daugirdas JT. Dialysis hypotension: a hemodynamic analysis. Kidney Int. 1991 Feb;39(2):233-46. — View Citation

Daugirdas JT. Pathophysiology of dialysis hypotension: an update. Am J Kidney Dis. 2001 Oct;38(4 Suppl 4):S11-7. Review. — View Citation

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 dial — View Citation

Ewing DJ, Winney R. Autonomic function in patients with chronic renal failure on intermittent haemodialysis. Nephron. 1975;15(6):424-9. — View Citation

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. — View Citation

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

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 — View Citation

Santoro A. Cardiovascular dialysis instability and convective therapies. Hemodial Int. 2006 Jan;10 Suppl 1:S51-5. Review. — 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

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. Review. — View Citation

Zoccali C, Benedetto FA, Tripepi G, Mallamaci F. Cardiac consequences of hypertension in hemodialysis patients. Semin Dial. 2004 Jul-Aug;17(4):299-303. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The superiority of OL-HDF over regular hemodialysis in decreasing the frequency of intradialytic hypertension episodes.		5 weeks
Primary	Mean arterial pressure (mm/Hg)		5 weeks
Primary	Cardiac index (l/min/m2)		5 weeks
Primary	Total peripheral resistance (dynes/sec/cm5)		5 weeks