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PARAMEDIC-2 Trial Results

 

‘For more than 50 years, treatment strategies have included the use of various drugs, but there is limited evidence that such treatments are effective’ (Perkins et al, 2018).

Now the PARAMEDIC-2 trial results are in…

  • 8014 patients of the 10, 623 initially selected were included in the trial.
  • Of these, 4015 were given adrenaline and 3999 a placebo.
  • Of those who were given adrenaline and survived until discharge, 39 (31.0%) out of 126 patients had a ‘severe neurological impairment’ and of those who were given the placebo, the same was true for ’16 of 90 patients [17.8%]’
    (Perkins et al, 2018).

Exclusions to the trial

  • ‘…those with anaphylaxis, pregnant women and children’ (below age 16).
  • After the pilot, life-threatening asthma as a suspected cause of the cardiac arrest was added as an exclusion because of ‘the potential overlap between the presentation of asthma and anaphylaxis’.
  • Anaphylaxis was excluded because adrenaline is considered potentially ‘beneficial’ for this condition
    (Warwick Clinical Trials Unit, 2018).

The trial only looked at the effects of the use of adrenaline during out-of-hospital cardiac arrest and not at the use of adrenaline during ROSC, which is a protocol that some Trusts follow (Warwick Clinical Trials Unit, 2018). In addition, this does not cover any treatment initiated by the hospital if the patient was transported there.

Conclusions

‘the benefits of epinephrine that were identified in our trial are small, since they would result in 1 extra survivor for every 112 patients treated. This number is less than the minimal clinically important difference that has been defined in previous studies.29,30 Among the survivors, almost twice the number in the epinephrine group as in the placebo group had severe neurologic impairment’ (Perkins et al, 2018).

Limitations

Perceived limitations include: ‘Information about the quality of CPR was limited to the first 5 minutes of cardiac arrest and involved fewer than 5% of the enrolled patients.’ (Perkins et al, 2018)

Further limitations to consider could be:

  • time to CPR
  • patient’s co-morbitities that weren’t already considered in the study

More information

Warwick’s Clinical Trials Unit have produced an infographic with more information here.

View the University of Warwick’s press release here.

References

NIHR, 2018. Investigating the role of adrenaline in cardiac arrest. Available Online: https://www.nihr.ac.uk/news/investigating-the-role-of-adrenaline-in-cardiac-arrest/8931 (Accessed 19/07/18)

Perkins, G.D. et al, 2018. A randomized trial of epinephrine in out-of-hospital cardiac arrest. New England Journal of Medicine. doi: 10.1056/NEJMoa1806842

Warwick Clinical Trials Unit, 2018. Available Online: https://warwick.ac.uk/fac/med/research/ctu/trials/critical/paramedic2/faqs/ (Accessed 19/07/18)

 

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