What is the clinical evidence from this study?

Study design: Other. Population: Shock (n=1679). Intervention: Dopamine vs. Norepinephrine. Primary outcome: Hierarchical composite of 28-day mortality, new use of renal-replacement therapy, and new-onset arrhythmia (WR 0.79, 95% CI 0.68-0.92, p=0.003).

What does this research mean for the field?

In patients with shock, dopamine results in significantly worse hierarchical clinical outcomes and higher probability of harm compared to norepinephrine across all subgroups, with no identifiable population benefiting from dopamine. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

September 10, 2024Critical CareOpen Access

Exploration of different statistical approaches in the comparison of dopamine and norepinephrine in the treatment of shock: SOAP II

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Key result

Dopamine yields ~21% fewer wins versus norepinephrine for mortality, RRT, and arrhythmia in shock.

WR 0.79
95% CI 0.68-0.92
P=0.003
n=1,679

Why the study?

Exploring clinical trial data using alternative statistical methods may enhance original findings and clarify heterogeneity in treatment effect for dopamine versus norepinephrine in shock management.

Does dopamine improve clinical outcomes compared to norepinephrine in patients with shock?

Population

1679 patients with shock enrolled in SOAP II trial

Comparison

Dopamine versus norepinephrine

Design

Reanalysis of randomized trial data using multiple statistical approaches including win-ratio and Bayesian methods

Follow-up

28 days

Authors

FZFernando G. Zampieri SBSean M. Bagshaw JVJean‐Louis Vincent

Discussion

Member takes

Overview

Norepinephrine should be preferred to dopamine in shock; confirms harm in SOAP II reanalysis.

Structured PICO

Does dopamine improve clinical outcomes compared to norepinephrine in patients with shock?

Population

1,679 critically ill patients with shock (average age 64.9 years, 43% female) randomized to dopamine or norepinephrine.

Intervention

Dopamine

Comparator

Norepinephrine

Outcome

Multiple endpoints including 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)composite

Main Result

Effect estimate: WR 0.79 (95% CI 0.68-0.92)

p-value: p=0.003

Reanalysis of the SOAP II trial using alternative statistical methods confirms that dopamine is associated with worse outcomes compared to norepinephrine across shock types, including cardiogenic and septic shock.

Limitations

Post-hoc analysis based on previously published data
SOAP II trial was published more than 10 years ago, which may limit applicability due to changes in ICU practices
Extensive number of analyses included
All endpoints are anchored to mortality, which was numerically higher in the dopamine group
Definitions of region of practical equivalence (ROPE) were arbitrary

Cite This Study

Zampieri et al. (2024) studied Shock (n=1,679). Dopamine vs. Norepinephrine was evaluated on Hierarchical composite of 28-day mortality, new use of renal-replacement therapy, and new-onset arrhythmia (WR 0.79, 95% CI 0.68-0.92, p=0.003). Dopamine resulted in significantly fewer wins compared to norepinephrine for a hierarchical composite of mortality, renal replacement therapy, and arrhythmia (WR 0.79) in patients with shock.

synapsesocial.com/papers/6aae0e5d31f0686ca400e375 https://doi.org/10.1186/s13054-024-05016-9

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September 10, 2024Critical CareOpen Access

Exploration of different statistical approaches in the comparison of dopamine and norepinephrine in the treatment of shock: SOAP II

View Full Paper

Ask AI

Bookmark

Key result

Dopamine yields ~21% fewer wins versus norepinephrine for mortality, RRT, and arrhythmia in shock.

WR 0.79
95% CI 0.68-0.92
P=0.003
n=1,679

Why the study?

Exploring clinical trial data using alternative statistical methods may enhance original findings and clarify heterogeneity in treatment effect for dopamine versus norepinephrine in shock management.

Does dopamine improve clinical outcomes compared to norepinephrine in patients with shock?

Population

1679 patients with shock enrolled in SOAP II trial

Comparison

Dopamine versus norepinephrine

Design

Reanalysis of randomized trial data using multiple statistical approaches including win-ratio and Bayesian methods

Follow-up

28 days

Authors

FZFernando G. Zampieri SBSean M. Bagshaw JVJean‐Louis Vincent

Discussion

Member takes

Overview

Norepinephrine should be preferred to dopamine in shock; confirms harm in SOAP II reanalysis.

Structured PICO

Does dopamine improve clinical outcomes compared to norepinephrine in patients with shock?

Population

1,679 critically ill patients with shock (average age 64.9 years, 43% female) randomized to dopamine or norepinephrine.

Intervention

Dopamine

Comparator

Norepinephrine

Outcome

Main Result

Effect estimate: WR 0.79 (95% CI 0.68-0.92)

p-value: p=0.003

Limitations

Post-hoc analysis based on previously published data
SOAP II trial was published more than 10 years ago, which may limit applicability due to changes in ICU practices
Extensive number of analyses included
All endpoints are anchored to mortality, which was numerically higher in the dopamine group
Definitions of region of practical equivalence (ROPE) were arbitrary

Cite This Study

synapsesocial.com/papers/6aae0e5d31f0686ca400e375 https://doi.org/10.1186/s13054-024-05016-9

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