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The following is a summary of “Exploration of different statistical approaches in the comparison of dopamine and norepinephrine in the treatment of shock: SOAP II,” published in the September 2024  issue of Critical Care by Zampieri et al.

Investigating alternative approaches for interpreting clinical trial data may uncover new insights and findings, as in the SOAP II trial published over a decade ago, which raises questions regarding the benefits of dopamine for shock management.

Researchers conducted a retrospective study to reevaluate the trial using various methods and the heterogeneity in treatment effect (HTE).

They analyzed patients from the SOAP II trial using different methods, such as the win-ratio (WR), Bayesian reanalysis by shock type, and risk-based explorations for HTE. These techniques were applied to endpoints such as a hierarchy of death, new use of renal-replacement therapy (RRT), and new-onset arrhythmia; 28-day mortality; a composite endpoint (mortality, new use of RRT, and new-onset arrhythmia); and days alive and free of ICU at 28 days (DAFICU28).

The results showed 1,679 patients (average age 64.9 years, 57% male, 62% with septic shock, and 17% with cardiogenic shock), favoring norepinephrine over dopamine. Using the WR approach, dopamine had rarer wins than norepinephrine (WR 0.79; 95% [CI] 0.68–0.92; P=0.003), observed in both shock subgroups. Bayesian reanalysis exhibited a probability of harm for dopamine of 0.95 for mortality, >0.99 for the composite endpoint, and 0.91 for days alive and free of ICU at 28 days (DAFICU28), with an effective impact in cardiogenic shock (0.92). The risk-based HTE analysis suggested that dopamine resulted in fewer DAFICU28 in the highest quartile of predicted mortality risk. The effect-based HTE model did not favor dopamine over norepinephrine for any combinations of age, type of shock, presence of cardiomyopathy, and sequential organ failure assessment (SOFA) score, with dopamine use where norepinephrine was linked to a 6% absolute increase in the composite endpoint.

They concluded that the harm associated with dopamine in managing shock was evident in patients with both septic and cardiogenic shock, with no subgroups showing a benefit over norepinephrine.

Source: ccforum.biomedcentral.com/articles/10.1186/s13054-024-05016-9