Against the background of the Rivers et al. trial on early goal-directed therapy (EGDT) in sepsis, the broad question of whether EGDT truly conferred a measurable benefit was addressed in three separate multicenter trials undertaken in three different parts of the world—the ProCESS (Protocol-Based Care for Early Septic Shock), ARISE (Australasian Resuscitation in Sepsis Evaluation), and ProMISe (Procolized Management in Sepsis) trials. The ProCESS trial was a multicenter study conducted in 31 centers in the USA, including 1351 patients, to evaluate the effectiveness of Early Goal-Directed Therapy (EGDT) in septic shock. It compared three approaches: EGDT, protocol-based standard care, and usual care. The study found that EGDT did not improve survival rates compared to the other two approaches. It also showed that less invasive resuscitation strategies were as effective as EGDT. This ARISE trial enrolled 1600 patients across 51 centers, primarily in Australia and New Zealand, to evaluate the efficacy of EGDT, a protocol-driven approach targeting specific hemodynamic goals, compared to usual care in the first 6 hours of septic shock management. The study found no significant difference in 90-day mortality between the EGDT and usual care groups. Similarly, there were no major differences in secondary outcomes such as organ support requirements or hospital stay duration. Importantly, the trial demonstrated that usual care, which has evolved significantly since EGDT was first proposed, is non-inferior in terms of patient outcomes. The ProMISe trial enrolled 1260 patients from 56 centers in the United Kingdom to evaluate EGDT, a protocolized approach involving specific hemodynamic targets, compared to usual care in the first 6 hours of septic shock management. The trial found no significant difference in 90-day mortality between the EGDT and usual care groups. Additionally, no substantial differences were observed in secondary outcomes, including organ support or length of stay. The findings highlighted that usual care, incorporating early recognition and prompt treatment of sepsis, achieved comparable outcomes to EGDT. The findings of these randomized controlled trials offered robust evidence that rigid EGDT protocols are not superior to contemporary sepsis care, emphasizing flexibility and individualized patient management in the treatment of septic shock.

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Goal-Directed Resuscitation in Sepsis: The Rivers et al., ProCESS, ARISE, and ProMISe Trials

  • Jose Chacko,
  • Donald B. Chalfin,
  • Ian Seppelt,
  • Swapnil Pawar,
  • Gagan Brar

摘要

Against the background of the Rivers et al. trial on early goal-directed therapy (EGDT) in sepsis, the broad question of whether EGDT truly conferred a measurable benefit was addressed in three separate multicenter trials undertaken in three different parts of the world—the ProCESS (Protocol-Based Care for Early Septic Shock), ARISE (Australasian Resuscitation in Sepsis Evaluation), and ProMISe (Procolized Management in Sepsis) trials. The ProCESS trial was a multicenter study conducted in 31 centers in the USA, including 1351 patients, to evaluate the effectiveness of Early Goal-Directed Therapy (EGDT) in septic shock. It compared three approaches: EGDT, protocol-based standard care, and usual care. The study found that EGDT did not improve survival rates compared to the other two approaches. It also showed that less invasive resuscitation strategies were as effective as EGDT. This ARISE trial enrolled 1600 patients across 51 centers, primarily in Australia and New Zealand, to evaluate the efficacy of EGDT, a protocol-driven approach targeting specific hemodynamic goals, compared to usual care in the first 6 hours of septic shock management. The study found no significant difference in 90-day mortality between the EGDT and usual care groups. Similarly, there were no major differences in secondary outcomes such as organ support requirements or hospital stay duration. Importantly, the trial demonstrated that usual care, which has evolved significantly since EGDT was first proposed, is non-inferior in terms of patient outcomes. The ProMISe trial enrolled 1260 patients from 56 centers in the United Kingdom to evaluate EGDT, a protocolized approach involving specific hemodynamic targets, compared to usual care in the first 6 hours of septic shock management. The trial found no significant difference in 90-day mortality between the EGDT and usual care groups. Additionally, no substantial differences were observed in secondary outcomes, including organ support or length of stay. The findings highlighted that usual care, incorporating early recognition and prompt treatment of sepsis, achieved comparable outcomes to EGDT. The findings of these randomized controlled trials offered robust evidence that rigid EGDT protocols are not superior to contemporary sepsis care, emphasizing flexibility and individualized patient management in the treatment of septic shock.