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Melatonin Use in the Intensive Care Elderly Population (MICE)

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ClinicalTrials.gov Identifier: NCT03013790
Recruitment Status : Unknown
Verified July 2017 by MICE Trial Group.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
MICE Trial Group

Brief Summary:
The investigators are studying the use of Melatonin in non-ventilated patients over the age of 65. Primary endpoint will be assesments of delirium, with secondary endpoints to include length of stay, use of anti-psychotic medications, and mortality

Condition or disease Intervention/treatment Phase
Delirium Melatonin Drug: Melatonin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Melatonin Use in the Intensive Care Elderly Population
Study Start Date : December 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Melatonin 5mg
This arm will be given 5mg tablets of Melatonin nightly for the duration of their hospital stay
Drug: Melatonin
Patients will receive Melatonin at 2 different doses or a placebo

Active Comparator: Melatonin 3mg
This arm will be given 3mg tablets of Melatonin nightly for the duration of their hospital stay
Drug: Melatonin
Patients will receive Melatonin at 2 different doses or a placebo

Placebo Comparator: Placebo
This arm will be given a Sucrose tablet nightly for the duration of their hospital stay
Drug: Melatonin
Patients will receive Melatonin at 2 different doses or a placebo




Primary Outcome Measures :
  1. Delirium [ Time Frame: Length of Hospital Stay, Average of 1 week ]

Secondary Outcome Measures :
  1. Use of Antipsychotic Medications [ Time Frame: Length of Hospital Stay, Average of 1 week ]
  2. Average RASS Score [ Time Frame: Length of Hospital Stay, Average of 1 week ]
  3. ICU days [ Time Frame: Length of Hospital Stay, Average of 1 week ]
  4. Hospital Days [ Time Frame: Length of Hospital Stay, Average of 1 week ]
  5. 30 day mortality [ Time Frame: 30 days post D/C ]
  6. 90 day mortality [ Time Frame: 90 days post D/C ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-ventilated Patients over the age of 65

Exclusion Criteria:

  • Patients with head trauma or Neurosurgical intervention
  • Patients <65 years of age
  • Patients with an expected life expectancy <48 hours
  • Blind patients
  • Patients with a seizure history
  • Patients with uncontrolled hypertension
  • Patients with a supratheraputic (>3.0) INR
  • Patients on strong CYP1A2 inhibitors: ciprofloxacin, fluvoxamine, methoxsalen, ofloxacin, primaquine
  • Patients who do not speak English or Spanish

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): NCT03013790


Contacts
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Contact: Mike Forte, DO 7195641542 mike_forte@parkviewmc.com
Contact: Josh Gordon, DO 7195641542 joshiah_gordon@parkviewmc.com

Locations
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United States, Colorado
Parkview Medical Center Recruiting
Pueblo, Colorado, United States, 81003
Contact: Mike Forte, DO    719-564-1542    mike_forte@parkviewmc.com   
Contact: Josh Gordon, DO    7195641542    joshiah_gordon@parkviewmc.com   
Sponsors and Collaborators
MICE Trial Group

Publications:

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Responsible Party: MICE Trial Group
ClinicalTrials.gov Identifier: NCT03013790     History of Changes
Other Study ID Numbers: MICE
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Melatonin
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants