Oral Melatonin in Critically Ill High-risk Patients

This study has been completed.
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
First received: May 4, 2007
Last updated: July 26, 2010
Last verified: January 2010
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 ill patients, and secondarily for preventing Delirium during their ICU stay and post-traumatic stress disorders after ICU discharge.

Condition Intervention Phase
Critically Ill Patients
Mechanically Ventilated Patients
Drug: Oral melatonin 3mg BID
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double Blind Trial to Evaluate Sedation and Quality of Life in High-risk, Critically Ill Patients Treated With Oral Melatonin

Resource links provided by NLM:

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Overall sedatives daily doses [ Time Frame: Discharge from ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of Delirium assessed with CAM-ICU [ Time Frame: Discharge from ICU ] [ Designated as safety issue: No ]
  • Prevalence of mental disorders [ Time Frame: 60 days after ICU discharge ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: Discharge from ICU ] [ Designated as safety issue: No ]
  • ICU mortality [ Time Frame: Discharge from ICU ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Sleep quantity assessed by wrist actigraphy [ Time Frame: Discharge from ICU ] [ Designated as safety issue: Yes ]

Enrollment: 96
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A - placebo
Identical tablets without the active principles. Each evening, nurses are requested to give 2 tablets at 8 PM and 12 PM
Drug: Placebo
Identical tablets without the active principles. Each evening nurses are requested to give 2 tablets at 8 PM and 12 PM
Active Comparator: B - melatonin
Identical tablets containing melatonin 3 mg Nurses are requested to give two tablets daily, at 8 PM and 12 PM.
Drug: Oral melatonin 3mg BID
Identical tablets containing melatonin 3 mg. Nurses are requested to give two tablets daily, at 8 PM and 12 PM
Other Name: MELATONIN 3 mg

  Show Detailed Description


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High Treatment > 1 day
  • Normal gastrointestinal function

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00470821

Azienda Ospedaliera San Paolo - Polo Universitario
Milano, Italy, 20142
Sponsors and Collaborators
University of Milan
Study Chair: Gaetano Iapichino, MD University of Milan
  More Information

Responsible Party: Giovanni Mistraletti, MD, Istituto di Anestesiologia e Rianimazione, Università di Milano
ClinicalTrials.gov Identifier: NCT00470821     History of Changes
Other Study ID Numbers: Mela-UniMi-0001 
Study First Received: May 4, 2007
Last Updated: July 26, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
critical patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 25, 2016