ANZCTR - Registration

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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 provided

9/06/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Improving sleep in Intensive Care

Scientific title

Effect of Exogenous Melatonin Administration in Critically Ill Patients on Delirium and Sleep: A Randomized Controlled Trial.

Secondary ID [1]

"Nil Known"

Universal Trial Number (UTN)

U1111-1250-6226

Trial acronym

MELATICU

Linked study record

Not Applicable

Health condition

Health condition(s) or problem(s) studied:

Sleep deprivation

ICU delirium

Critical illness

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

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

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Placebo was a sucrose solution

Control group

Placebo

Outcomes

Primary outcome [1]

Primary outcome measure:
1) number of Sleep arousal
By utilising the gold standard for sleep recording: polysomnogram

Timepoint [1]

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

Primary outcome [2]

2) length of sleep REM phase
Utilising the gold standard measure for sleep assessment: polysomnogram

Timepoint [2]

Same timepoint than for first outcome measure, day 5 of recruitment

Secondary outcome [1]

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

Timepoint [1]

Measured at the end of the intervention (day 5 after initiating melatonin / placebo)

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

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-- Patients with an inflammatory response
-- Septic patients
-- Burns
-- Patients on vasopressors
-- Patients with underlying psychiatric disorders on baseline antipsychotic medications

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerized sequence generation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

N/A

Phase

Phase 2

Type of endpoint/s

Efficacy

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).

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

30/12/2009

Date of last participant enrolment

Anticipated

Actual

20/08/2016

Date of last data collection

Anticipated

Actual

26/08/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

RBWH Research Foundation - Queensland Health 2011

Address [1]

Royal Brisbane and Womens' Hospital-Research Foundation
Butterfield Street
Herston 4029
QLD

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

St Lucia QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro North Hospitals and Health Service HREC

Ethics committee address [1]

Level 13, Block 7, Royal Brisbane and Women’s Hospital, Butterfield street,  HERSTON QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/09/2009

Approval date [1]

16/12/2009

Ethics approval number [1]

HREC/09/QRBW/262

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.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Judith Bellapart

Address

Royal Brisbane and Women's Hospital
Department of Intensive Care
3rd Level Ned Hanlon Building
Butterfield Street
Herston 4029
QLD

Country

Australia

Phone

+61 736468897

Fax

+61754338706

judith.bellapart@health.qld.gov.au

Contact person for public queries

Name

judith Bellapart

Address

Royal Brisbane and Women's Hospital
Department of Intensive Care
3rd Level Ned Hanlon Building
Butterfield Street
Herston 4029
QLD

Country

Australia

Phone

+61 447177585

Fax

judithbellapart@gmail.com

Contact person for scientific queries

Name

Judith Bellapart

Address

Royal Brisbane and Women's Hospital
Department of Intensive Care
3rd Level Ned Hanlon Building
Butterfield Street
Herston 4029
QLD

Country

Australia

Phone

+61 736468897

Fax

+61754338706

judith.bellapart@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after de-identification.

When will data be available (start and end dates)?

After publication: Beginning 30th July 2020 and end date 30th December 2020

Available to whom?

Only researchers who provide a methodologically sound proposal.

Available for what types of analyses?

To achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator : judith.bellapart@health.qld.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7690	Study protocol			judith.bellapart@health.qld.gov.au		379634-(Uploaded-21-04-2020-12-26-48)-Study-related document.doc
7691	Ethical approval			judithbellapart@gmail.com		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.

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