A randomised trial of the pro-phylactic use of melatonin in critically ill patients to evaluate if this leads to a reduction in incidence of delirium (Pro-MEDIC study)

Phase 2

Completed

• Conditions: Delirium; Neurological - Other neurological disorders

• Registration Number: ACTRN12616000436471
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

The early use of melatonin did not result in reduced delirium in intensive care patients. We also did not see a change in the quality or duration of sleep or any of the other secondary outcomes between the patients who received melatonin and those who received placebo

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-06
• Study Completion: 2019-11-29
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

Patients admitted to the Intensive Care Unit, identified by the treating intensivist as expected to have an ICU length of stay >72 hours. Patients must be enrolled within 48 hours of their ICU admission.

Exclusion Criteria

1 Patients already on melatonin before their admission to ICU
2 Prior hypersensitivity reaction to any of the components of the study drug
3 Patients expected to be discharged within 72 hrs of their ICU admission
4 Non English speaking
5 Expected or inevitable death within next 48 hours
6 Patients that are not expected to improve adequately to be able to be assessed with a CAM-ICU score during their ICU stay
7 Patients that are not able to be assessed due to neurological problems that would affect their ability to participate in a CAM-ICU assessment (as judged by treating physician)
8 No enteral route – melatonin not available in intravenous formulation
9 Pregnancy or breastfeeding.
10. Hepatic impairment defined as Alanine Transferase (ALT) >500 IU/L, previous liver transplant or liver cirrhosis categories Childs-Pugh B and C.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium free assessments (as measured by CAM-ICU score)[Twice daily assessment - percentage of delirium free assessments during ICU stay or 14 days (whichever is shorter)]