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Table 2 Reasons for lack of survival improvements in sepsis clinical trials

From: Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure

• Declining mortality rates over time
• Over-estimated treatment effects
• Suboptimal pre-clinical models
• Knowledge of pathophysiology is still evolving, making pathophysiologic targets difficult to identify
• Incorrect treatment targets
• Heterogeneity of the syndrome
• Heterogeneity of the patient population
• Improbability that a single treatment can impact key pathophysiologic processes that influence all-cause mortality