High versus low blood-pressure target in patients with septic shock.
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Asfar Pierre, Meziani Ferhat, Hamel Jean-François, Grelon Fabien, Megarbane Bruno, Anguel Nadia, Mira Jean-Paul, Dequin Pierre-François, Gergaud Soizic, Weiss Nicolas, Legay François, Le Tulzo Yves, Conrad Marie, Robert René, Gonzalez Frédéric, Guitton Christophe, Tamion Fabienne, Tonnelier Jean-Marie, Guezennec Pierre, Van Der Linden Thierry, Vieillard-Baron Antoine, Mariotte Eric, Pradel Gaël, Lesieur Olivier, Ricard Jean-Damien, Hervé Fabien, du Cheyron Damien, Guerin Claude, Mercat Alain, Teboul Jean-Louis, Radermacher Peter, SEPSISPAM Investigators
Аннотация
METHODS: In a multicenter, open-label trial, we randomly assigned 776 patients with septic shock to undergo resuscitation with a mean arterial pressure target of either 80 to 85 mm Hg (high-target group) or 65 to 70 mm Hg (low-target group). The primary end point was mortality at day 28.
RESULTS: At 28 days, there was no significant between-group difference in mortality, with deaths reported in 142 of 388 patients in the high-target group (36.6%) and 132 of 388 patients in the low-target group (34.0%) (hazard ratio in the high-target group, 1.07; 95% confidence interval [CI], 0.84 to 1.38; P=0.57). There was also no significant difference in mortality at 90 days, with 170 deaths (43.8%) and 164 deaths (42.3%), respectively (hazard ratio, 1.04; 95% CI, 0.83 to 1.30; P=0.74). The occurrence of serious adverse events did not differ significantly between the two groups (74 events [19.1%] and 69 events [17.8%], respectively; P=0.64). However, the incidence of newly diagnosed atrial fibrillation was higher in the high-target group than in the low-target group. Among patients with chronic hypertension, those in the high-target group required less renal-replacement therapy than did those in the low-target group, but such therapy was not associated with a difference in mortality.
CONCLUSIONS: Targeting a mean arterial pressure of 80 to 85 mm Hg, as compared with 65 to 70 mm Hg, in patients with septic shock undergoing resuscitation did not result in significant differences in mortality at either 28 or 90 days. (Funded by the French Ministry of Health; SEPSISPAM ClinicalTrials.gov number, NCT01149278.).