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Oral Melatonin in Critically Ill High-risk Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470821
First Posted: May 8, 2007
Last Update Posted: July 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Milan
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Prevalence of Delirium assessed with CAM-ICU [ Time Frame: Discharge from ICU ]
  • Prevalence of mental disorders [ Time Frame: 60 days after ICU discharge ]
  • ICU length of stay [ Time Frame: Discharge from ICU ]
  • ICU mortality [ Time Frame: Discharge from ICU ]
  • Hospital mortality [ Time Frame: Hospital discharge ]
  • Sleep quantity assessed by wrist actigraphy [ Time Frame: Discharge from ICU ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 4, 2007
First Posted: May 8, 2007
Last Update Posted: July 28, 2010
Last Verified: January 2010

Keywords provided by University of Milan:
melatonin
actigraphy
sedation
critical patients
ICU

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