Sepsis & septic shock · Protocolised early resuscitation
Trial of early, goal-directed resuscitation for septic shock
| Design | Multicentre pragmatic randomised controlled trial |
|---|---|
| Treatment | Strict early goal-directed therapy protocol |
| Control | Usual care |
| Population | 1260 patients with septic shock identified early and given intravenous antibiotics and fluid resuscitation |
| Follow-up | 90 days |
| Primary endpoint | All-cause mortality at 90 days |
| Result | By 90 days, 184 of 623 (29.5%) in the EGDT group and 181 of 620 (29.2%) in the usual-care group had died — relative risk 1.01 (95% CI 0.85 to 1.20). EGDT increased costs without improving outcomes. |
| Secondary endpoints | Organ support, length of stay, health-related quality of life, cost-effectiveness |
In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation, hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome.
The trial authors, in the published abstract
The third and final replication failure. Note the condition embedded in the authors' own conclusion: patients were identified early and given antibiotics and fluid. That is the part of Rivers EGDT that survived, and the catheters and protocols are the part that did not.
Mouncey PR, Osborn TM, Power GS, et al. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 2015 Apr 2;372(14):1301-11.