Hemodialysis Clinical Trial
Official title:
Assessment of Hemocontrol Biofeedback System Efficiency on Long Term Blood Pressure Control, Nursing Interventions, and Quality of Life in Hemodialysis Patients: a Randomized Controlled Trial
Volume overload contributes significantly to the pathogenesis of hypertension in
hemodialysis patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts
ultrafiltration rate and dialysate conductivity according to blood volume variations during
dialysis, has been suggested to improve hemodynamic tolerance and thus facilitate fluid
removal.
This randomized controlled trial was designed to compare the use of HC with standard
hemodialysis to test the hypothesis that the use of the HC system may lower home blood
pressure in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints
are a variation in the percentage of dialysis sessions requiring nurses’ interventions for
intra-dialytic hypotension and a change in the health-related quality of life of HD
patients.
Hypertension is a common problem in patients undergoing chronic maintenance hemodialysis
(HD) with a reported prevalence of 50 to 90 % [Hörl, 2002]. As a major risk factor for
cardiovascular disease, hypertension contributes to the high rate of morbidity and mortality
in ESRD patients [Foley, 1996; Port, 1999]. For a majority of dialysis patients, volume
overload (VO) plays a major role in the pathogenesis of hypertension [Fishbane, 1996;
Rahman, 2000; Ventura, 1997] and removing excess volume can often normalize blood pressure
[Fishbane, 1996]. Unfortunately, correcting VO frequently proves to be difficult because of
hemodynamic instability during HD sessions. As much as 20 to 50% of dialysis patients
present with symptoms of intradialytic hypotension (IDH) [Santoro, 2002]. IDH increases
nursing work load and negatively affects the efficacy of dialysis and the quality of life of
HD patients. Different measures are used to avoid IDH, such as limitation of salt and water
intake, avoidance of antihypertensive medication before dialysis, utilization of low
temperature dialysate, and modeling of ultrafiltration and/or dialysate conductivity. These
measures often generate mixed results.
The Hemocontrol (HC) biofeedback system (Gambro®) has been reported to reduce hemodynamic
instability and hypotensive episodes during hemodialysis [Basile, 2001; Begin, 2002; Ronco,
2000; Santoro, 1994; Santoro, 1998; Santoro, 2002; Wolkotte, 2002]. The HC system consists
in a fully integrated biofeedback system that monitors and regulates blood volume
contraction during hemodialysis through software-driven adjustments of ultrafiltration rate
and dialysate conductivity. By improving hemodynamic tolerance during dialysis, the use of
the HC system has been suggested to facilitate fluid removal and correction of VO, leading
to improved control of hypertension.
The present randomized controlled trial was designed to test the hypothesis that the use of
the HC system would lower home BP in comparison with standard hemodialysis as a primary
endpoint. Secondary endpoints are a variation in the percentage of HD sessions requiring
nurses’ interventions and a change in the health-related quality of life of HD patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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