The Healthy Heart-Mind Trial: Efficacy of melatonin for decreasing the incidence and severity of delirium following cardiac surgery

Phase 2

Completed

• Conditions: delirium; cardiac surgery; Mental Health - Other mental health disorders; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615000819527
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-10
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Aged 50 years and older
2. Undergoing elective or semi-elective cardiac surgery (on or off cardiopulmonary bypass) for coronary artery bypass grafting (CABG) and/or valvular surgery

Exclusion Criteria

1. Decline or are unable to give informed consent
2. Are undergoing emergency surgery
3. Are not fluent in written or spoken English (for the purposes of being able to complete the study assessments and questionnaires)
4. Have a contraindication to taking melatonin, such as a prior allergic reaction
5. Are currently using melatonin
6. Have a diagnosis of dementia or score 19 or less on the Telephone Interview for Cognitive Status
7. Score 15 or greater on the alcohol use disorders identification test (AUDIT)

Study & Design

• Study Type: Interventional
• Study Design: Not specified