American journal of kidney diseases : the official journal of the National Kidney Foundation · 2011
Automatic adaptive system dialysis for hemodialysis-associated hypotension and intolerance: a noncontrolled multicenter trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Colì Luigi, La Manna Gaetano, Comai Giorgia, Ursino Mauro, Ricci Davide, Piccari Matteo, Locatelli Francesco, Di Filippo Salvatore, Cristinelli Luciano, Bacchi Massimo, Balducci Alessandro, Aucella Filippo, Panichi Vincenzo, Ferrandello Francesco Paolo, Tarchini Renzo, Lambertini Domenica, Mura Carlo, Marinangeli Giancarlo, Di Loreto Ermanno, Quarello Francesco, Forneris Giacomo, Tancredi Maurizio, Morosetti Massimo, Palombo Giuditta, Di Luca Marina, Martello Mauro, Emiliani Giuseppe, Bellazzi Roberto, Stefoni Sergio
Аннотация
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.
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.