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. 2018 Nov 23;2018(11):CD009783. doi: 10.1002/14651858.CD009783.pub2

Martinez 2017.

Trial name or title Prophylactic melatonin for delirium in intensive care (Pro‐MEDIC): study protocol for a randomised controlled trial.
Country: Australia
Methods Multicentre, randomized double‐blind placebo‐controlled trial
Participants Adult ICU patient with a ICU LOS of minimum 72 hours of admission. Expected: 850 adult ICU patients
Interventions Interventions
  1. 4 mg melatonin enterally at 21:00 every day from enrolment until 14 days or to ICU discharge, whichever comes first


Control
  1. Placebo tablet

Outcomes
  1. Proportion of delirium‐free assessments

  2. Overall prevalence of delirium

  3. Duration of delirium

  4. Severity of delirium

  5. Sleep quality

  6. ICU and hospital length of stay

  7. Morbidity and mortality (28/90 days)

  8. Healthcare costs


CAM‐ICU will be used as measurement of delirium.
Starting date Trial registered 20 December 2015
Contact information ed.martinez@hnehealth.nsw.gov.au
Notes Study number: ACTRN12616000436471
Status: Recruiting
Contact with author: email sent 5 July 2017 for status ‐ awaiting response from corresponding author