MULLET

MULLET Feature ImageThe Mulled Wine versus Normal Saline Evaluation Trial for Rehydration in The Critical Care Setting

First published online Friday December 18th. NEJM (Northern Elf Journal of Musings). DOI: 25:12:2015.123

Clinical Question

  • In critical care doctors, does mulled wine compared to normal saline, improve the sense of well-being and ICU length of stay?

Design

  • Multi-centre, multi-country RCT
  • Pseudo-randomisation. Those who will be attending SMACC Dublin (#smaccDUB) were allocated to the mulled wine group as part of training and socialisation
  • Single blinding. Drink bottles were blackened so that the colour of the consumed liquid was not noted by the participants. However, the taste was not disguised. And those allocated to the wine became blind
  • Outcome assessor blinding – as a mark of sympathy to the participants outcome assessors also became blind
  • Pilot trial period with subsequent adjustment of sample size following the release of the second run of SMACC tickets
  • Powered at 80% to detect a 10% absolute improvement in favourable characteristics

Setting

  • 55 centres through Australia, New Zealand, United Kingdom, Ireland, Scandinavia, USA, South Africa  and Canada
  • October – December 2015

Population

  • Inclusion: 4000 critical care doctors. 2000 allocated to the mulled wine group, 2000 to the normal saline group
  • Exclusion: Doctors with pre-existing alcoholic liver disease

Intervention

  • Doctors in the mulled wine group were required to drink 5 bottles of 200ml mulled wine (12 % alcohol) once a week

Control

  • Doctors in the normal saline group were required to drink 5 bottles of 200ml of normal saline once a week

Outcome

  • Primary outcome: well-being quality of life score measured at 1 hour after imbibing
    • There was a statistically significant higher assessment of quality of life in the mulled wine group one hour after ingestion
    • Binomial analysis of ‘how are you feeling now?’ Good/Excellent 90% in mulled wine group versus 20% in normal saline group (p=0.01)
  • Secondary Outcome:
    • well-being quality of life score after consumption
      • measured at 4 hours: 80% vs 30% p=0.04
      • measured at 12 hours: 10% vs 40% p= 0.03
    • length of stay as a critical care doctor
      • Those who consumed mulled wine reported that they were intending to stay on as a critical care doctor in 100% of cases, whereas only 40% of the normal saline group planned to continue as a critical care doctor

Authors’ Conclusions

  • In critical care doctors who were required to rehydrate with mulled wine once a week, quality of life was significantly higher as was the intention to continue working in the critical care environment

Strengths

  • Trial protocol published a priori in Santa’s newsletter
  • Participating centres all had evidence of prior exposure to rehydration with similar fluids and this peaked in June 2015 in Chicago
  • Doctor centred outcomes rather than surrogate endpoints
  • Pragmatic design and based on similar current practices
  • Complete follow-up make the validity of the results strong although many participants had a high fragility index at the 12 hour mark

Weaknesses

  • The binomial distribution of results means the statistical robustness is less than an ordinal analysis, but with such clear margins the results are highly likely to be true
  • The pseudo-randomised nature of the trial may mean that those who are planning to attend SMACC have a natural love for life and positivity and this could have biased the result

The Bottom Line

  • In critical care doctors, imbibing mulled wine in the pre-Christmas season was associated with a significantly higher well-being score and intention to remain as a critical care doctor

External Links

  • [article] MULLET Trial: The Mulled Wine versus Normal Saline Evaluation Trial for Rehydration in The Critical Care Setting

Metadata

Summary author: @celiabradford
Summary date: 18th December 2015
Peer-review editor: @DuncanChambler, @davidslessor, @avkwong, @stevemathieu75  & the post publication peer review #FOAMed elves

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