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Home The Classics Emergency Classics

The SOAP-II trial: First-line vasopressor for shock management [Classics Series]

byAimme Li, MDandAndrew Cheung, MD MBA
February 21, 2014
in Emergency Classics, General Medicine Classics, The Classics
Reading Time: 3 mins read
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Image: PD

1. There were no significant differences in 28-day, 6-month, or 12-month mortality when comparing dopamine and norepinephrine as first-line vasopressors in managing shock.

2. Dopamine was associated with a significantly higher rate of arrhythmias, as well as severe arrhythmias that required stopping the study drug, when compared to norepinephrine.

Original Date of Publication: March 4, 2010

Study Rundown: The SOAP-II trial demonstrated that there were no significant differences in mortality when comparing dopamine and norepinephrine as first-line vasopressors. Dopamine, however, was associated with a significantly higher rate of arrhythmias, as well as severe arrhythmias that led to withholding of the study drug. Moreover, the study demonstrated significantly increased 28-day mortality with dopamine use in a prespecified subgroup of patients who had cardiogenic shock. These findings challenged the American College of Cardiology-American Heart Association recommendation at the time, which suggested using dopamine as the first-line agent in patients suffering from acute myocardial infarction and hypotension.

Please click to read study in NEJM

In Depth [randomized, controlled study]: Originally published in 2010 in NEJM, the SOAP-II trial compared the use of norepinephrine and dopamine as first-line agents in treating patients suffering from circulatory shock. At the time, guidelines and recommendations suggested that either agent could be used as the first-line vasopressor. Some studies, however, had suggested that dopamine use was a predictor of mortality in shock. A total of 1,679 patients were enrolled from 8 centres in Belgium, Austria, and Spain. Patients were eligible if they were 18 years of age and required a vasopressor for treatment of shock. Shock was defined as a mean arterial pressure <70 mmHg or systolic blood pressure <100 mmHg, despite adequate fluid resuscitation, and clinical signs of tissue hypoperfusion (e.g., altered mental state, mottled skin, urine output <0.5 mL/kg/hour). The primary outcome was 28-day mortality, while secondary outcomes included mortality in the intensive care unit (ICU), in hospital mortality, 6- and 12-month mortality, and days requiring ICU care or organ support.

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There were no significant differences between the two groups in terms of 28-day mortality, or mortality in the ICU, in hospital, at 6- months, or at 12-months. There were no significant differences between the two groups in terms of number of days requiring ICU care or organ support. The study demonstrated a significantly higher incidence of arrhythmias in the dopamine group compared to the norepinephrine group (24.1% vs. 12.4%, P<0.001). The dopamine group also experienced a significantly higher incidence of severe arrhythmia, which necessitated stopping the study drug (6.1% vs. 1.6%, P<0.001). In the prespecified subgroup of patients suffering cardiogenic shock, 28-day mortality was significantly higher in the dopamine group compared to the norepinephrine group (P=0.03).

By Aimee Li, M.D.; Andrew Cheung, M.D.

© 2013 2minutemedicine.com. All rights reserved. No works may be reproduced without written consent from 2minutemedicine.com. Disclaimer: We present factual information directly from peer reviewed medical journals. No post should be construed as medical advice and is not intended as such by the authors or by 2minutemedicine.com. PLEASE SEE A HEALTHCARE PROVIDER IN YOUR AREA IF YOU SEEK MEDICAL ADVICE OF ANY SORT. Content is produced in accordance with fair use copyrights solely and strictly for the purpose of teaching, news and criticism. No benefit, monetary or otherwise, is realized by any participants or the owner of this domain.

Tags: dopaminenorepinephrineshockSOAP trialSOAP-IIvasopressor
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