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Trial registered on ANZCTR
Registration number
ACTRN12620000661976
Ethics application status
Approved
Date submitted
21/04/2020
Date registered
9/06/2020
Date last updated
9/06/2020
Date data sharing statement initially provided
9/06/2020
Date results information initially provided
9/06/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Improving sleep in Intensive Care
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Scientific title
Effect of Exogenous Melatonin Administration in Critically Ill Patients on Delirium and Sleep: A Randomized Controlled Trial.
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Secondary ID [1]
301026
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"Nil Known"
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Universal Trial Number (UTN)
U1111-1250-6226
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Trial acronym
MELATICU
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Linked study record
Not Applicable
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Health condition
Health condition(s) or problem(s) studied:
Sleep deprivation
317141
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ICU delirium
317142
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Critical illness
317408
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Condition category
Condition code
Anaesthesiology
315294
315294
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Drug name: Melatonin (Generic name)
Dose administered: 6 mg during 7 time points between 9pm and 01 am, as follows:
Real drug administration time schedule Time (hours. minutes in relation to melatonin dose) Measurement / sample
21h 0.00 First 3mg dose of study drug
0.00 Blood sample 1
0.30 Blood sample 2
0.45 Blood sample 3
1.00 Blood sample 4
22h 1.00 Administration of 0.5mg study drug
1.30 Blood sample 5
2.00 Blood sample 6
23h 2.00 Administration of 0.5mg study drug
24h 3.00 Administration of 0.5mg study drug
01h 4.00 Administration of 0.5mg study drug
02h 5.00 Administration of 0.5mg study drug
03 h 6.00 Administration of 0.5mg study drug
7.00 Blood sample 7
9.00 Blood sample 8
Duration of administration: Five consecutive nights
Mode of administration: syrup (Enteral administration)
Such intervention will be monitored through the clinical audit tool (Metavision) and CIS (Clinical Information System) at the bedside
Assessment completion on the last day of recruitment, day five of intervention
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Intervention code [1]
317379
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Prevention
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Intervention code [2]
317380
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Treatment: Drugs
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Comparator / control treatment
Placebo was a sucrose solution
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Primary outcome measure:
1) number of Sleep arousal
By utilising the gold standard for sleep recording: polysomnogram
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Assessment method [1]
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Timepoint [1]
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Primary outcome measure on the last day of the intervention (day 5 of intervention)
This will be a second and last polysomnogram recording which will be done on the last day of drug / placebo
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Primary outcome [2]
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2) length of sleep REM phase
Utilising the gold standard measure for sleep assessment: polysomnogram
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Assessment method [2]
323750
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Timepoint [2]
323750
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Same timepoint than for first outcome measure, day 5 of recruitment
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Secondary outcome [1]
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Change in ICU related delirium assessed by applying the CAM and RASS scales which are the validated scales for Delirium and Agitation in Critical care
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Assessment method [1]
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Timepoint [1]
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Measured at the end of the intervention (day 5 after initiating melatonin / placebo)
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Eligibility
Key inclusion criteria
* Ventilated patients in their weaning phase
* Integrity of the enteral system (capacity to absorb enteral medication)
All patients will be ICU inpatients
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-- Patients with an inflammatory response
-- Septic patients
-- Burns
-- Patients on vasopressors
-- Patients with underlying psychiatric disorders on baseline antipsychotic medications
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to either group was concealed.
Use of random number generators and enclosed envelopes to allocate patients into groups
Allocation was performed by a third party: research coordinators without the investigators ' involvement
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
N/A
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
For this Phase II study, a significant reduction in relative risk was planned to determine a significant clinical signal. Using a reduction in delirium from 30% to 5% with a significance level of 5% and a power of 80%, 86 patients in total were meant to enroll. Data was analyzed on an intention to treat basis. The study was designed with the guidelines of the CONSORT statement to adhere to requirements for randomized controlled trials. Univariate data was described using medians with interquartile ranges (IQR) and 95% confidence intervals (95%CI) unless otherwise specified. Univariate analysis used chi-square, Fisher’s exact, Wilcoxon rank sum and Kruskal-Wallis tests as appropriate. Analysis used Stata 15.1 statistical software (College Station, Texas. United States of America).
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
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Actual
30/12/2009
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Date of last participant enrolment
Anticipated
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Actual
20/08/2016
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Date of last data collection
Anticipated
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Actual
26/08/2016
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Sample size
Target
80
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
16509
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
30066
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
305471
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Charities/Societies/Foundations
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Name [1]
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RBWH Research Foundation - Queensland Health 2011
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Address [1]
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Royal Brisbane and Womens' Hospital-Research Foundation
Butterfield Street
Herston 4029
QLD
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Country [1]
305471
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Australia
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Primary sponsor type
University
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Name
University of Queensland
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Address
St Lucia QLD 4072
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
305923
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Address [1]
305923
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Country [1]
305923
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305787
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Metro North Hospitals and Health Service HREC
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Ethics committee address [1]
305787
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Level 13, Block 7, Royal Brisbane and Women’s Hospital, Butterfield street, HERSTON QLD 4029
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Ethics committee country [1]
305787
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Australia
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Date submitted for ethics approval [1]
305787
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21/09/2009
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Approval date [1]
305787
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16/12/2009
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Ethics approval number [1]
305787
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HREC/09/QRBW/262
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Summary
Brief summary
This is a study attempting to treat delirium in critically ill patients, by improving the quality and length of their sleep.
The main hypothesis is that the bright and noisy environment within Intensive Care units difficult patients' sleep and those who sleep, have fragmented and shallow (non-restorative) sleep.
The intervention is based on the administration of melatonin, a safe drug that has been shown to improve sleep in other groups of people.
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Trial website
N/A
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Judith Bellapart
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Address
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Royal Brisbane and Women's Hospital
Department of Intensive Care
3rd Level Ned Hanlon Building
Butterfield Street
Herston 4029
QLD
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Country
101594
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Australia
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Phone
101594
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+61 736468897
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Fax
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+61754338706
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Email
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[email protected]
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Contact person for public queries
Name
101595
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Dr judith Bellapart
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Address
101595
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Royal Brisbane and Women's Hospital
Department of Intensive Care
3rd Level Ned Hanlon Building
Butterfield Street
Herston 4029
QLD
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Country
101595
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Australia
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Phone
101595
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+61 447177585
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Fax
101595
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Email
101595
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[email protected]
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Contact person for scientific queries
Name
101596
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Dr Judith Bellapart
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Address
101596
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Royal Brisbane and Women's Hospital
Department of Intensive Care
3rd Level Ned Hanlon Building
Butterfield Street
Herston 4029
QLD
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Country
101596
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Australia
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Phone
101596
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+61 736468897
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Fax
101596
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+61754338706
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Email
101596
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
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When will data be available (start and end dates)?
After publication: Beginning 30th July 2020 and end date 30th December 2020
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Available to whom?
Only researchers who provide a methodologically sound proposal.
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Available for what types of analyses?
To achieve the aims in the approved proposal
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How or where can data be obtained?
Access subject to approvals by Principal Investigator :
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7690
Study protocol
[email protected]
379634-(Uploaded-21-04-2020-12-26-48)-Study-related document.doc
7691
Ethical approval
[email protected]
379634-(Uploaded-21-04-2020-12-27-57)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF