2 research outputs found
Plasmapheresis in severe sepsis and septic shock: a prospective, randomised, controlled trial
Objective: To determine the therapeutic efficacy and safety of
plasmapheresis in the treatment of patients with severe sepsis and septic shock.
Design: Prospective, randomised, clinical trial with a planned, midstudy, interim analysis. Setting: Intensive care unit in a university hospital in Archangels, Russia.
Patients: Consecutive patients with severe sepsis or septic shock.
Interventions: One hundred and six patients were randomised to receive either standard therapy or an add-on treatment with plasmapheresis.
Measurements and results: The primary endpoint was 28-day survival. Septic shock was diagnosed in 57% of the plasmapheresis-treated patients and 54% of the control patients. Mean APACHE III score at entry was 56.4 in the plasmapheresis group and 53.5 in the control group.
The 28-day, all-cause mortality rate was 33.3% (18/54) in the plasmapheresis group and 53.8% (28/52) in the control group. This represents a relative risk for fatal outcome in the plasmapheresis group of 0.61, an absolute risk reduction of 20.5% and a number of patients needed to treat of
4.9. Apart from six transient episodes of hypotension and one allergic
reaction to fresh frozen plasma, no adverse reactions were attributable
to the plasmapheresis treatment in this study.
Conclusions: Plasmapheresis
may be an important adjuvant to conventional treatment to reduce
mortality in patients with severe sepsis or septic shock. Plasmapheresis
is a safe procedure in the treatment of septic patients. A prospective
randomised multicentre trial is warranted to confirm our results
and to determine which subgroups of septic patients will benefit most from
this treatment modality
Intravenous NPA for the treatment of infarcting myocardium early: InTIME-II, a double-blind comparison on of single-bolus lanoteplase vs accelerated alteplase for the treatment of patients with acute myocardial infarction
Aims to compare the efficacy and safety of lanoteplase, a single-bolus thrombolytic drug derived from alteplase tissue plasminogen activator, with the established accelerated alteplase regimen in patients presenting within 6 h of onset of ST elevation acute myocardial infarction. Methods and Results 15 078 patients were recruited from 855 hospitals worldwide and randomized in a 2:1 ratio to receive either lanoteplase 120 KU. kg-1 as a single intravenous bolus, or up to 100 mg accelerated alteplase given over 90 min. The primary end-point was all-cause mortality at 30 days and the hypothesis was that the two treatments would be equivalent. By 30 days, 6.61% of alteplase-treated patients and 6.75% lanoteplase-treated patients had died (relative risk 1.02). Total stroke occurred in 1.53% alteplase- and 1.87% lanoteplase-treated patients (ns); haemorrhagic stroke rates were 0.64% alteplase and 1.12% lanoteplase (P=0.004). The net clinical deficit of 30-day death or non-fatal disabling stroke was 7.0% and 7.2%, respectively. By 6 months, 8.8% of alteplase-treated patients and 8.7% of lanoteplase-treated patients had died. Conclusion Single-bolus weight-adjusted lanoteplase is an effective thrombolytic agent, equivalent to alteplase in terms of its impact on survival and with a comparable risk-benefit profile. The single-bolus regimen should shorten symptoms to treatment times and be especially convenient for emergency department or out-of-hospital administration. (C) 2000 The European Society of Cardiology