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The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

Primary Purpose

Delirium, Sleep Deprivation

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ramelteon
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery.
  • Age > 18 years

Exclusion Criteria:

  • Pregnancy
  • Cirrhosis of any etiology
  • Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon)
  • Any contraindication to EEG/Sleep recording
  • Non-English speaking (who are unable to complete delirium questionnaires)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Ramelteon

    Arm Description

    Patients will receive a Placebo tablet every evening.

    Patients will receive Ramelteon 8mg every evening.

    Outcomes

    Primary Outcome Measures

    Duration of Delirium
    Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
    Total Duration of Sleep
    Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.

    Secondary Outcome Measures

    Number of Participants With Delirium
    Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
    Average Daily Critical Care Pain Observation Tool (CPOT)
    average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation.
    Length of Hospital Stay
    Length of ICU Stay
    Measures of Light Quality in the Patient's Room
    Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.
    Measures of the Sound Levels in the Patient's Room
    Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.

    Full Information

    First Posted
    December 28, 2015
    Last Updated
    February 1, 2022
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02691013
    Brief Title
    The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
    Official Title
    The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    February 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sleep deprivation is known to affect brain function but is often ignored in the sickest patients including those in the intensive care unit after major surgery. In these patients, the levels of melatonin can also be altered. Melatonin is a hormone secreted in the brain that maintains the body's sleep-wake, or circadian, cycle. The investigators want to test whether improving sleep quality affects the risk of developing confusion (delirium) in patients having clot removed from their lung (open heart surgery). In order to improve sleep quality, the investigators will conduct a study of Ramelteon, a medication that mimics the activity of melatonin and measure its effects on levels of melatonin and monitor sleep.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium, Sleep Deprivation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive a Placebo tablet every evening.
    Arm Title
    Ramelteon
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive Ramelteon 8mg every evening.
    Intervention Type
    Drug
    Intervention Name(s)
    Ramelteon
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Duration of Delirium
    Description
    Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.
    Time Frame
    Twice daily for up to 10 days
    Title
    Total Duration of Sleep
    Description
    Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.
    Time Frame
    Daily for up to 10 days
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Delirium
    Description
    Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument
    Time Frame
    Twice daily for up to 10 days
    Title
    Average Daily Critical Care Pain Observation Tool (CPOT)
    Description
    average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation.
    Time Frame
    10 days
    Title
    Length of Hospital Stay
    Time Frame
    Duration of hospital admission
    Title
    Length of ICU Stay
    Time Frame
    Duration of hospital admission
    Title
    Measures of Light Quality in the Patient's Room
    Description
    Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.
    Time Frame
    3 days
    Title
    Measures of the Sound Levels in the Patient's Room
    Description
    Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are admitted to UCSD for a planned PTE surgery. Age > 18 years Exclusion Criteria: Pregnancy Cirrhosis of any etiology Current use of any atypical antipsychotic including Fluvoxamine (contra-indicated with Ramelteon) Any contraindication to EEG/Sleep recording Non-English speaking (who are unable to complete delirium questionnaires)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Owens
    Organizational Affiliation
    8686577118
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20845391
    Citation
    Al-Aama T, Brymer C, Gutmanis I, Woolmore-Goodwin SM, Esbaugh J, Dasgupta M. Melatonin decreases delirium in elderly patients: a randomized, placebo-controlled trial. Int J Geriatr Psychiatry. 2011 Jul;26(7):687-94. doi: 10.1002/gps.2582. Epub 2010 Sep 15. Erratum In: Int J Geriatr Psychiatry. 2014 May;29(5):550.
    Results Reference
    background
    PubMed Identifier
    22419624
    Citation
    Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth. 2012 Apr;108(4):572-80. doi: 10.1093/bja/aes035.
    Results Reference
    background
    PubMed Identifier
    24554232
    Citation
    Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320.
    Results Reference
    background
    PubMed Identifier
    31567351
    Citation
    Jaiswal SJ, Vyas AD, Heisel AJ, Ackula H, Aggarwal A, Kim NH, Kerr KM, Madani M, Pretorius V, Auger WR, Fernandes TM, Malhotra A, Owens RL. Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy. Crit Care Med. 2019 Dec;47(12):1751-1758. doi: 10.1097/CCM.0000000000004004.
    Results Reference
    derived

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    The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery

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