The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial

Jan 30, 2016Trials

Melatonin to help prevent confusion after heart surgery: study plan for a clinical trial

AI simplified

Circadian Biology on OpenScience ↗PubMed ↗DOI ↗

Abstract

A total of 210 adult participants will be recruited to assess the impact of 3 mg melatonin on delirium incidence following cardiac surgery.

Melatonin is being investigated for its potential role in reducing delirium after major cardiac surgery.
The primary outcome is to compare the incidence of delirium between those receiving melatonin and those receiving a placebo within 7 days post-surgery.
Secondary outcomes include evaluating the severity and duration of delirium, hospital stay length, and referrals to mental health services.
Additional assessments will focus on changes in depressive and anxiety symptoms, along with cognitive performance at discharge and 3 months later.

AI simplified

BACKGROUND: Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo.

METHODS/DESIGN: The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery.

DISCUSSION: The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery.

TRIAL REGISTRATION: The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

Full Text

We can’t show the full text here under this license. Use the link below to read it at the source.

View full text ↗

The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief