None listed
Conditions
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.
Interventions
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 Administ
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
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ventilated patients in their weaning phase * Integrity of the enteral system (capacity to absorb enteral medication) All patients will be ICU inpatients
Exclusion criteria
-- Patients with an inflammatory response -- Septic patients -- Burns -- Patients on vasopressors -- Patients with underlying psychiatric disorders on baseline antipsychotic medications
Outcome results
None listed