An interventional study of NICaS in Intradialytic Hypotension, sponsored by Western Galilee Hospital-Nahariya. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-11.
Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Diagnostic
Rationale and objectives
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Western Galilee Hospital-Nahariya is the lead sponsor of 87 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: NICaS
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).
The superiority of OL-HDF over regular hemodialysis in decreasing the frequency of intradialytic hypertension episodes.
Time frame: 5 weeks
Mean arterial pressure (mm/Hg)
Time frame: 5 weeks
Cardiac index (l/min/m2)
Time frame: 5 weeks
Total peripheral resistance (dynes/sec/cm5)
Time frame: 5 weeks
Plan to share: Undecided
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Western Galilee Hospital-Nahariya