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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will receive a Placebo tablet every evening. |
|
| Ramelteon | Active Comparator | Patients will receive Ramelteon 8mg every evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramelteon | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Delirium | Measured twice daily during the ICU stay using the Confusions Assessment Method instrument. | Twice daily for up to 10 days |
| 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. | Daily for up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Delirium | Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument | Twice daily for up to 10 days |
| Average Daily Critical Care Pain Observation Tool (CPOT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Owens | 8686577118 | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20845391 | Background | 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. | |
| 22419624 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo |
| FG001 | Ramelteon | Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
120 enrolled. 3 participants withdrew prior to receiving any drug. Reporting the results of the 117 who were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will receive a Placebo tablet every evening. Placebo |
| BG001 | Ramelteon | Patients will receive Ramelteon 8mg every evening. Ramelteon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Delirium | Measured twice daily during the ICU stay using the Confusions Assessment Method instrument. | Posted | Median | Inter-Quartile Range | hours | Twice daily for up to 10 days |
|
10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Owens | University of California San Diego | 858-657-5258 | rowens@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2015 | Jul 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C495910 | ramelteon |
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|
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.
| 10 days |
| Length of Hospital Stay | Duration of hospital admission |
| Length of ICU Stay | Duration of hospital admission |
| 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. | 3 days |
| 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. | 3 days |
| 24554232 | Background | 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. |
| 36702822 | Derived | Jaiswal SJ, Bagsic SRS, Takata E, Kamdar BB, Ancoli-Israel S, Owens RL. Actigraphy-based sleep and activity measurements in intensive care unit patients randomized to ramelteon or placebo for delirium prevention. Sci Rep. 2023 Jan 26;13(1):1450. doi: 10.1038/s41598-023-28095-0. |
| 31567351 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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. | Due to funding & logistical constraints, only a subset of subjects would've been able to do the electroencephalography (EEG) monitoring used for sleep assessment. Thus, Total Duration of Sleep was not measured and we focused on our a priori secondary outcome of incident delirium, a change made before the start of data collection or analysis. | Posted | Daily for up to 10 days |
|
|
| Secondary | Number of Participants With Delirium | Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument | Posted | Count of Participants | Participants | Twice daily for up to 10 days |
|
|
|
| Secondary | 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. | Not Posted | Dec 2021 | 10 days | Participants |
| Secondary | Length of Hospital Stay | Posted | Median | Inter-Quartile Range | days | Duration of hospital admission |
|
|
|
| Secondary | Length of ICU Stay | Posted | Median | Inter-Quartile Range | days | Duration of hospital admission |
|
|
|
| Secondary | 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. | Not Posted | Dec 2021 | 3 days | Participants |
| Secondary | 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. | Not Posted | Dec 2021 | 3 days | Participants |
| 4 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Ramelteon | Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon | 3 | 59 | 0 | 59 | 0 | 59 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |