Gestern ist die PARAMEDIC2 Studie im New England Journal of Medicine erschienen. In diesem großen RCT mit 8014 Patienten wurde im prähospitalen Setting die Anwendung von Adrenalin gegen Placebo bei erwachsenen Patienten mit Herz-Kreislauf-Stillstand untersucht.
Das primäre Endpunkt war das 30-Tage Überleben, der sekundäre Endpunkt eine gutes neurologisches Outcome nach 30 Tagen.
Hinsichtlich des primären Outcomes hatte die Adrenalin-Gruppe einen leicht signifikanten Vorteil (2.4% vs. 3.2%, P=0.02), es gab jedoch keinen signifikanten Unterschied hinsichtlich des neurologischen Outcomes (2.2% vs. 1.9%), es zeigte sich sogar, dass in der Adrenalin Gruppe mehr Patienten mit einem sehr schlechten neurologischen Outcome entlassen wurden (31.0% vs. 17.8%).
In Kürze: Adrenalin erhöht das primäre Überleben, es gibt jedoch keine Vorteile beim neurologischen Outcome.
Link zur Studie (NEJM – Open Access)
BACKGROUND
Concern about the use of epinephrine as a treatment for out-of-hospital cardiac arrest led the International Liaison Committee on Resuscitation to call for a placebo-controlled trial to determine whether the use of epinephrine is safe and effective in such patients.
METHODS
In a randomized, double-blind trial involving 8014 patients with out-of-hospital cardiac arrest in the United Kingdom, paramedics at five National Health Service ambulance services administered either parenteral epinephrine (4015 patients) or saline placebo (3999 patients), along with standard care. The primary outcome was the rate of survival at 30 days. Secondary outcomes included the rate of survival until hospital discharge with a favorable neurologic outcome, as indicated by a score of 3 or less on the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]).
RESULTS
At 30 days, 130 patients (3.2%) in the epinephrine group and 94 (2.4%) in the placebo group were alive (unadjusted odds ratio for survival, 1.39; 95% confidence interval [CI], 1.06 to 1.82; P=0.02). There was no evidence of a significant difference in the proportion of patients who survived until hospital discharge with a favorable neurologic outcome (87 of 4007 patients [2.2%] vs. 74 of 3994 patients [1.9%]; unadjusted odds ratio, 1.18; 95% CI, 0.86 to 1.61). At the time of hospital discharge, severe neurologic impairment (a score of 4 or 5 on the modified Rankin scale) had occurred in more of the survivors in the epinephrine group than in the placebo group (39 of 126 patients [31.0%] vs. 16 of 90 patients [17.8%]).
CONCLUSIONS
In adults with out-of-hospital cardiac arrest, the use of epinephrine resulted in a significantly higher rate of 30-day survival than the use of placebo, but there was no significant between-group difference in the rate of a favorable neurologic outcome because more survivors had severe neurologic impairment in the epinephrine group.