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Oral Melatonin in Critically Ill High-risk Patients

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00470821
First received: May 4, 2007
Last updated: July 26, 2010
Last verified: January 2010
History of Changes
  Purpose

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:

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin
U.S. FDA Resources

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
Other Name: PLACEBO
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470821

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

No publications provided

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:
melatonin
actigraphy
sedation
critical patients
ICU

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

ClinicalTrials.gov processed this record on May 19, 2013