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

Completed

• Conditions: ervous System Diseases: Sleep disorders; Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN47578325
• Lead Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep and delirium.

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures