90-day follow-up of patients treated with Drotrecogin Alfa (activated) for severe sepsis: a Belgian open label study
| Autor: | Daniel De Backer, Johan Decruyenaere, Magali Sartral, Hugues Trine, T. Haentjens, Thomas Wagner, Peter Rogiers, Jan Raemaekers, Herbert D. Spapen, Pierre-François Laterre |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Multiple Organ Failure Kaplan-Meier Estimate law.invention Sepsis Randomized controlled trial Anti-Infective Agents law Intensive care Internal medicine Epidemiology medicine Humans Infusions Intravenous Aged business.industry Drotrecogin alfa General Medicine Middle Aged medicine.disease Intensive care unit Recombinant Proteins Surgery Clinical trial Survival Rate Treatment Outcome Bacteremia Female business medicine.drug Follow-Up Studies Protein C |
| Zdroj: | Acta clinica Belgica. 64(1) |
| ISSN: | 1784-3286 |
| Popis: | Severe sepsis is the major cause of mortality in intensive care units (ICUs). The BOOST study (= B (Belgian) OO (Open Label) ST (Study)) is a Belgian open-label trial designed to pragmatically assess the safety and efficacy of Drotrecogin Alfa (activated) (DAA), the only registered treatment in this indication with favourable ratio benefit/risk.Adult patients with severe sepsis and 2 or more sepsis-induced organ dysfunctions (OD) within the 48-hour period preceding the treatment (DAA at 24 microg/kg/h for 96 hours), were included between January 2003 and October 2003. Platelet count30 000/mm3 and increased risk for bleeding were exclusion criteria. Mortality and location were evaluated at 28 and 90 days.Of the 100 included patients, 97 (median age: 66 years; men/women: 57/40) were treated and completed the study. The predominant infection sites were lung (49%) and abdomen (29%) and 35% had had recent surgery. The mean and median numbers of OD were 3.4 and 3.0, respectively, and most patients (80 %; 77/97) had 3 or more organ failures at baseline, predominantly respiratory (95%) and cardiovascular (87%). The mean APACHE II score was 25.3 (range: 6-53). The 28-day mortality rate was 32.0% (90% CI: 24.2-39.7) and increased with the number of OD: from 15% (1.9-28.1) for2 ODs, to 71% (52.4-88.8) for 5 ODs. At day 28, the 66 surviving patients were located in general ward (35%), in the ICU (32%) or at home (30%). The 90-day mortality rate was 42% (90% CI: 34.0-50.5), with most of the survivors (73%) staying at home. Eight serious adverse events, including 4 bleedings, were reported between study days 2 and 5, in 5 patients (5.2%) and led to death in 2 patients (2.1%).Despite a higher severity of illness at baseline, this phase IV open-label long-term study in Belgian ICUs shows consistent results with previous studies with DAA. Importantly, most of the surviving patients at day 90 were staying at home. |
| Databáze: | OpenAIRE |
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