AIM: To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus? liver assist system in a randomized, controlled study. METHODS: Twenty-four patients were randomized to eith...AIM: To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus? liver assist system in a randomized, controlled study. METHODS: Twenty-four patients were randomized to either the study group or to one of two control groups: Fractionated Plasma Separation Adsorption and Dialysis, Prometheus? system (Study group; n = 8); Molecular Adsorbent Recirculation System (MARS)? (Control group 1, n = 8); or hemodialysis (Control group 2; n = 8). All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. RESULTS: Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group (P = 0.008). No adverse effects were observed in any of the groups. Creatinine levels significantly decreased in the MARS group (P = 0.03) and hemodialysis group (P = 0.04). Platelet count deceased in the Prometheus group (P = 0.04).CONCLUSION: Extra-corporal liver support with Prometheus is proven to be safe in patients with end- stage liver disease but does not exert the beneficial effects on arterial pressure as seen in the MARS group.展开更多
基金The NOVO Nordic Foundation, Savvrksejer Jeppe & Ovita Mindelegat, Fabricant Vilhelm Pedersen & Wifes Mindelegat, A.P. Moller Scientific Foundation, the Danish Medical Association Research Fund and the Laerdal Foundation for Acute Medicine, and by an unrestricted grant from the Fresenius Medical Care GmBH
文摘AIM: To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus? liver assist system in a randomized, controlled study. METHODS: Twenty-four patients were randomized to either the study group or to one of two control groups: Fractionated Plasma Separation Adsorption and Dialysis, Prometheus? system (Study group; n = 8); Molecular Adsorbent Recirculation System (MARS)? (Control group 1, n = 8); or hemodialysis (Control group 2; n = 8). All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. RESULTS: Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group (P = 0.008). No adverse effects were observed in any of the groups. Creatinine levels significantly decreased in the MARS group (P = 0.03) and hemodialysis group (P = 0.04). Platelet count deceased in the Prometheus group (P = 0.04).CONCLUSION: Extra-corporal liver support with Prometheus is proven to be safe in patients with end- stage liver disease but does not exert the beneficial effects on arterial pressure as seen in the MARS group.
