Status:
COMPLETED
Oral Melatonin in Critically Ill High-risk Patients
Lead Sponsor:
University of Milan
Conditions:
Critically Ill Patients
Mechanically Ventilated Patients
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
Sleep disruptions are extremely common in high-risk critically ill patients. The investigators want to analyse oral melatonin potentialities as a sedative and a free-radicals scavenger for critically ...
Detailed Description
The physiological secretion of such melatonin follows a circadian rhythm: melatonin plasma concentration increases with the dark reaching a peak around to midnight and then gradually decreases (Reiter...
Eligibility Criteria
Inclusion
- High Treatment \> 1 day
- Normal gastrointestinal function
Exclusion
- Status asthmaticus
- Chronic renal failure under dialytic treatment
- Severe hepatopathy (Child-Pugh class = C)
- Comatous patients (GCS \< 12)
- Head trauma, severe neurological diseases (ictus cerebri, SAH, ...)
- Intoxicated patients
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00470821
Start Date
May 1 2007
End Date
May 1 2010
Last Update
July 28 2010
Active Locations (1)
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1
Azienda Ospedaliera San Paolo - Polo Universitario
Milan, Italy, 20142