Therapy Comparison of dopamine and norepinephrine in the treatment of shock
This review may be edited
Summary
Posted By:	Elizabeth Sweetman and Gordon Doig
E-Mail:	easweetm@nsccahs.health.nsw.gov.au
Posted Date:	27/04/10
Title:	Comparison of dopamine and norepinephrine in the treatment of shock
Authors:	De Backer D, Biston P, Devriendt J, Madl C, Chochrad D, Aldecoa C, Brasseur A, Defrance P, Gottignies P, Vincent JL; SOAP II Investigators
Reference:	N Engl J Med. 2010 Mar 4;362(9):779-89
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Abstract:	BACKGROUND: Both dopamine and norepinephrine are recommended as first-line vasopressor agents in the treatment of shock. There is a continuing controversy about whether one agent is superior to the other. METHODS: In this multicenter, randomized trial, we assigned patients with shock to receive either dopamine or norepinephrine as first-line vasopressor therapy to restore and maintain blood pressure. When blood pressure could not be maintained with a dose of 20 microg per kilogram of body weight per minute for dopamine or a dose of 0.19 microg per kilogram per minute for norepinephrine, open-label norepinephrine, epinephrine, or vasopressin could be added. The primary outcome was the rate of death at 28 days after randomization; secondary end points included the number of days without need for organ support and the occurrence of adverse events. RESULTS: The trial included 1679 patients, of whom 858 were assigned to dopamine and 821 to norepinephrine. The baseline characteristics of the groups were similar. There was no significant between-group difference in the rate of death at 28 days (52.5% in the dopamine group and 48.5% in the norepinephrine group; odds ratio with dopamine, 1.17; 95% confidence interval, 0.97 to 1.42; P=0.10). However, there were more arrhythmic events among the patients treated with dopamine than among those treated with norepinephrine (207 events [24.1%] vs. 102 events [12.4%], P<0.001). A subgroup analysis showed that dopamine, as compared with norepinephrine, was associated with an increased rate of death at 28 days among the 280 patients with cardiogenic shock but not among the 1044 patients with septic shock or the 263 with hypovolemic shock (P=0.03 for cardiogenic shock, P=0.19 for septic shock, and P=0.84 for hypovolemic shock, in Kaplan-Meier analyses). CONCLUSIONS: Although there was no significant difference in the rate of death between patients with shock who were treated with dopamine as the first-line vasopressor agent and those who were treated with norepinephrine, the use of dopamine was associated with a greater number of adverse events. (ClinicalTrials.gov number, NCT00314704.) 2010 Massachusetts Medical Society
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
	Yes. Allocation concealment was maintained with sealed and opaque envelopes which were opened in pharmacy. There was no mention of the envelopes being sequentially numbered.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	Yes all study patients were accounted for in this trials results. There was not loss to follow up in either study group for the primary outcome, 28 day mortality. The authors state some loss to follow up for hospital outcome and for 6 (85% follow-up) and 12 month (61% follow-up) outcomes (p. 782). Greater than 20% loss to follow-up may be considered unacceptable.
2b. Were patients analyzed in the groups to which they were randomized?
	Yes.
3. Were patients, health workers, and study personnel blind to treatment?
	The doctors and nurses administering the study drugs, local investigators and research personnel were blinded to treatment assignments (p. 780)
4. Were the groups similar at the start of the trial?
	Yes patient groups were similar at baseline (see table 1, p. 784). P-values were not reported in Table 1. P-values may be a useful guide to identify variables that are potential confounders.
5. Aside from the experimental intervention, were the groups treated equally?
	Table 3 is reasonably comprehensive. It is likely the groups were treated the same.
What are the Results?
1. How large was the treatment effect?
	Primary Outcome: Day 28 Mortality: No significant differences between the rate of death at 28 days in the Dopamine group (52.5%)vs the Norepinephrine group (48.5%);(4% absolute difference, 95% CI -0.78 to 8.78, p = 0.10) Test of interaction was negative for the sub-group analysis.
2. How precise was the estimate of the treatment effect?
	See above for 95% Confidence Interval.
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	We rarely use dopamine for this indication in Australia.
2. Were all clinically important outcomes considered?
	Yes.
3. Are the likely treatment benefits worth the potential harms and costs?
	Potential harms: 6.1% (52 patients) in the dopamine group vs 1.6% (13 patients) in the norepinephrine group had their study intervention discontinued owing to severe arrhythmias. It is unlikely dopamine will begin to be used for this indication in Australia.
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