Original Investigation
Dialysis
Automatic Adaptive System Dialysis for Hemodialysis-Associated Hypotension and Intolerance: A Noncontrolled Multicenter Trial

https://doi.org/10.1053/j.ajkd.2011.01.030Get rights and content

Background

Hemodialysis is complicated by a high incidence of intradialytic hypotension and disequilibrium symptoms caused by hypovolemia and a decrease in extracellular osmolarity. Automatic adaptive system dialysis (AASD) is a proprietary dialysis system that provides automated elaboration of dialysate and ultrafiltration profiles based on the prescribed decrease in body weight and sodium content.

Study Design

A noncontrolled (single arm), multicenter, prospective, clinical trial.

Setting & Participants

55 patients with intradialytic hypotension or disequilibrium syndrome in 15 dialysis units were studied over a 1-month interval using standard treatment (642 sessions) followed by 6 months using AASD (2,376 sessions).

Intervention

AASD (bicarbonate dialysis with dialysate sodium concentration and ultrafiltration rate profiles determined by the automated procedure).

Outcomes

Primary and major secondary outcomes were the frequency of intradialytic hypotension and symptoms (hypotensive events, headache, nausea, vomiting, and cramps), respectively.

Results

More stable intradialytic systolic and diastolic blood pressures with lower heart rate were found using AASD compared with standard treatment. Sessions complicated by hypotension decreased from 58.7% ± 7.3% to 0.9% ± 0.6% (P < 0.001). The incidence of other disequilibrium syndrome symptoms was lower in patients receiving AASD. There were no differences in end-session body weight, interdialytic weight gain, or presession natremia between the standard and AASD treatment periods.

Limitations

A noncontrolled (single arm) study, no crossover from AASD to standard treatment.

Conclusions

This study shows the long-term clinical efficacy of AASD for intradialytic hypotension and disequilibrium symptoms in a large number of patients and dialysis sessions.

Section snippets

Setting and Participants

The study was a noncontrolled (single arm) multicenter prospective clinical trial evaluating a group of patients receiving standard hemodialysis or hemodiafiltration (treatment at baseline) and presenting with dialysis intolerance. Patients were monitored for 1 month using the treatment they were receiving at baseline (the run-in phase) followed by a 6-month treatment with AASD divided into two 3-month periods.

Patients selected for the study had intradialytic hypotension or disequilibrium

Results

An Italian noncontrolled multicenter (15 dialysis units) prospective clinical trial was carried out from September 2007 to September 2008 to confirm the clinical efficacy of AASD in the long term (6 months) in 55 patients during 2,376 dialysis sessions.

Patients were all older than 18 years and at baseline had been undergoing hemodialysis 3 times a week for at least 6 months. Patient and dialysis session characteristics are listed in Table 1.

Seven patients dropped out of the study: 1 patient

Discussion

The pathogenesis of intradialytic complications is multifactorial. The main factor is plasma water loss through ultrafiltration, with a decrease in extracellular space and blood volume. The decrease in intradialytic osmolarity causes an additional loss of plasma water due to the shift from the extracellular to the intracellular space.11 The extracellular space decrease induces hypotension, whereas the intracellular space increase induces disequilibrium symptoms.3, 12, 13 Many investigators

Acknowledgements

Support: The study was supported in part by the Fondazione Cassa di Risparmio in Bologna, project no. 2007/0234 “Innovazioni diagnostiche e terapeutiche nell'approccio alle criticità immunologiche del paziente nel percorso Dialisi-Trapianto di Rene” (Principal Investigator, Prof Stefoni).

Financial Disclosure: The authors declare that they have no relevant financial interests.

References (52)

  • A.J. Collins et al.

    The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis

    Clin J Am Soc Nephrol

    (2009)
  • J. Donauer

    Hemodialysis-induced hypotension: impact of technologic advances

    Semin Dial

    (2004)
  • W. Sulowicz et al.

    Dialysis induced hypotension—a serious clinical problem in renal replacement therapy

    Med Pregl

    (2007)
  • D. Germin Petrovic

    Effect of automated blood volume control on the incidence of intra-dialysis hypotension

    Acta Med Croatica

    (2003)
  • B.G. Stegmayr

    Ultrafiltration and dry weight—what are the cardiovascular effects?

    Artif Organs

    (2003)
  • J.T. Daugirdas et al.

    Handbook of Dialysis

    (2007)
  • W.L. Henrich

    Hemodynamic stability during dialysis and cardiovascular disease in end-stage renal disease patients

    Am J Kidney Dis

    (1999)
  • H. Ebel et al.

    Impact of profile haemodialysis on intra-/extracellular fluid shifts and the release of vasoactive hormones in elderly patients on regular dialysis treatment

    Nephron

    (1997)
  • M.M. Trinh-Trang-Tan et al.

    Molecular basis for the dialysis disequilibrium syndrome: altered aquaporin and urea transporter expression in the brain

    Nephrol Dial Transplant

    (2005)
  • C.L. Chen et al.

    A preliminary report of brain edema in patients with uremia at first hemodialysis: evaluation by diffusion-weighted MR imaging

    AJNR Am J Neuroradiol

    (2007)
  • A.C. Guyton

    Textbook of Medical Physiology

    (1991)
  • S. Di Filippo et al.

    Sodium removal during pre-dilution haemofiltration

    Nephrol Dial Transplant

    (2003)
  • K.S. Rabindranath et al.

    Haemodiafiltration, haemofiltration and haemodialysis for end-stage kidney disease

    Cochrane Database Syst Rev

    (2006)
  • H.L. Tang et al.

    Sodium ramping reduces hypotension and symptoms during haemodialysis

    Hong Kong Med J

    (2006)
  • R.M. Raja

    Sodium profiling in elderly haemodialysis patients

    Nephrol Dial Transplant

    (1996)
  • B. Straver et al.

    The effect of profiled hemodialysis on intra-dialytic hemodynamics when a proper sodium balance is applied

    Blood Purif

    (2002)
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    Originally published online May 23, 2011.

    Trial registration: www.ClinicalTrials.gov; study number: NCT01241994.

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