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Clinical Trials/ISRCTN47578325
ISRCTN47578325
Completed
Not Applicable

Evaluation of melatonin therapy on sleep and delirium in intensive care patients

Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)0 sites48 target enrollmentSeptember 12, 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ervous System Diseases: Sleep disorders
Sponsor
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Enrollment
48
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 12, 2003
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Eligibility Criteria

Inclusion Criteria

  • Patients admitted to the adult general intensive care unit with acute respiratory failure requiring mechanical ventilation and then a tracheostomy to assist weaning.

Exclusion Criteria

  • 1\. Expected length of stay of less than five further days
  • 2\. Previously treated for sleep disturbances
  • 3\. Not receiving target enteral feed volume or aspirates greater than 200mls
  • 4\. Previous history of convulsions
  • 5\. Psychiatric or neurological disease
  • 6\. Excessive alcohol consumption (equal to or greater than 50 units per week)
  • 7\. Recreational drug use
  • 8\. Sleep apnoea
  • 9\. Severe heart failure (NYHA III/ IV)
  • 10\. Sedative infusions must have been discontinued for more than 24 hours (propofol and alfentanil) or more than 36 hours (morphine and midazolam) with a Sedation Agitation Score (SAS) \> 3

Outcomes

Primary Outcomes

Not specified

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