What is the Second Simplified Acute Physiology Score (SAPS II) trial?

From the Guidelines

The SOAP II trial was a multicenter, randomized controlled trial that compared the effects of dopamine and norepinephrine as first-line vasopressor agents in the treatment of shock, with a primary focus on mortality and morbidity outcomes. The trial's findings have significantly influenced the management of shock in clinical practice, particularly in the context of septic shock, which is a critical condition that can arise in neutropenic patients, as discussed in the guidelines for managing sepsis in such patients 1.

Key Findings and Implications

• The SOAP II trial enrolled a large number of patients with various types of shock, including septic shock, which is relevant to the management of neutropenic patients who are at high risk of developing sepsis and septic shock 1.
• The primary outcome of the trial was mortality, which is a critical consideration in the management of shock and sepsis, as highlighted in the guidelines for managing sepsis in neutropenic patients 1.
• The trial's results have implications for the management of shock in clinical practice, particularly in the context of septic shock, and highlight the importance of selecting the appropriate vasopressor agent to minimize morbidity and mortality.

Clinical Practice Implications

• The SOAP II trial's findings support the use of norepinephrine as the first-line vasopressor agent in the treatment of shock, including septic shock, due to its association with lower mortality and fewer adverse events compared to dopamine 1.
• The trial's results also highlight the importance of careful patient selection and monitoring when using vasopressor agents, particularly in patients with cardiac conditions or other comorbidities that may increase the risk of adverse events.
• In the context of managing sepsis in neutropenic patients, the SOAP II trial's findings emphasize the need for prompt and effective treatment of septic shock to minimize morbidity and mortality, as discussed in the guidelines for managing sepsis in such patients 1.

From the Research

SOAP II Trial Overview

• The SOAP II trial is a clinical trial that compared the effects of dopamine and norepinephrine in the treatment of shock 2.
• The trial has been reanalyzed using alternative methods to enhance the original study's findings and provide new insights 2.

Trial Objectives and Methods

• The SOAP II trial aimed to evaluate the effectiveness of dopamine and norepinephrine in the treatment of shock, including septic and cardiogenic shock 2.
• The trial used a variety of methods, including the win-ratio approach, Bayesian reanalysis, and explorations for heterogeneity in treatment effect (HTE) 2.

Trial Results

• The results of the SOAP II trial favored norepinephrine over dopamine, with dopamine having fewer wins compared to norepinephrine 2.
• The Bayesian reanalysis showed a high probability of harm associated with dopamine, including a higher probability of mortality, composite endpoint, and fewer days alive and free of ICU 2.

Clinical Implications

• The results of the SOAP II trial suggest that norepinephrine is the preferred vasopressor for the treatment of septic shock, with dopamine not being recommended for any subgroup of patients 2, 3.
• The trial's findings are consistent with current experts' recommendations, which position norepinephrine as the first-line vasopressor in septic shock 3.