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JOURNAL CLUB CRITIQUE
Dell’Anna A. M., Taccone F. S.
Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium
Three randomized clinical trials have recently provided data on the lack of effectiveness of “early-goal directed therapy” (EGDT) (i.e. optimization of tissue oxygenation in the first 6 hours since sepsis diagnosis using different therapeutic interventions based on the assessment of the central venous oxygen saturation to titrate such interventions) in the initial management of patients with septic shock. In a first trial including 31 US hospitals (the ProCESS study, N.=1341), three different therapeutic strategies (EGDT vs. protocol-based therapy vs. usual care) were compared and no difference in the primary endpoint (60-day mortality) was found (EGDT 21%, protocol-based therapy 18% and usual care 19%). No significant difference in death by 90 days or in other secondary outcomes, including serious adverse events, was found, as well. A second trial (ARISE, N.=1600), mostly conducted in Australia and New Zealand, randomized patients to EGDT or usual care. Ninety-day mortality was similar between groups (19% vs. 19%, respectively; P=0.90) and no other differences in secondary endpoints were recorded between the two groups. A third study (ProMISe, N.=1260) included patients in 56 hospitals across England, randomly assigned to EGDT or usual care. By 90 days, mortality was similar between groups (29% vs. 29%, respectively; P=0.90). Moreover, EGDT significantly increased costs and was associated with a longer hospital length of stay. We discussed some issues related to the differences between these studies and the pivotal paper from Rivers et al. and how EGDT should be still considered in the treatment of sepsis.