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TerminatedPhase 2ACTRN12620000661976

Improving sleep in Intensive Care

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

Sponsor

University of Queensland

Enrollment

80 participants

Start Date

Dec 30, 2009

Study Type

Interventional

Conditions

ICU delirium

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria3

  • Ventilated patients in their weaning phase
  • Integrity of the enteral system (capacity to absorb enteral medication)
  • All patients will be ICU inpatients

Exclusion Criteria5

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

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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 melat

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

Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12620000661976