Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Delirium- and coma-free days |
The average number of delirium- and coma-free days as defined by Richmond Agitation-Sedation Scale (RASS) greater than -4 (RASS score is a range from -5 to +4, the lower score indicates comatose state, the higher score indicates more awakeness/agitation) and Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score greater than 3 (CAM-ICU-7 score ranges from 0 to 7, the higher score indicates more severe delirium). |
Until discharge or up to 30 days of hospitalization, whichever is sooner. |
|
Secondary |
Delirium assessment score Confusion Assessment Method-Intensive Care Unit-7 (CAM-ICU-7) in Ramelteon group compared to the placebo group. |
Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score will be measured to assess delirium. Score ranges from minimum 0 to maximum 7, which is obtained as a sum of each category of CAM-ICU-7 assessment, where scores 0-2 indicate no delirium and greater than 3 indicate delirium, and the higher score (greater than 3) indicates more severe delirium. Higher CAM-ICU-7 score indicates a worse outcome. |
Until discharge or up to 30 days of hospitalization, whichever is sooner. |
|
Secondary |
Change in the delirium assessment scores (CAM-ICU-7) from baseline score on day one of enrolment in ramelteon group compared to the placebo group. |
Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score will be measured to assess delirium. Score ranges from minimum 0 to maximum 7, which is obtained as a sum of each category of CAM-ICU-7 assessment, where scores 0-2 indicate no delirium and greater than 3 indicate delirium, and the higher score (greater than 3) indicates more severe delirium. Higher CAM-ICU-7 score indicates a worse outcome. Each participant's individual CAM-ICU-7 scores will be compared throughout their hospital stay to assess the presence/absence of delirium as well as its severity if delirium is present. |
Until discharge or up to 30 days of hospitalization, whichever is sooner. |
|
Secondary |
Number of ICU and hospital days. |
The average length of stay in the ICU and hospital, in days. |
Until discharge or up to 30 days of hospitalization, whichever is sooner. |
|
Secondary |
Hours of total sleep, nighttime sleep and number of awakenings in ramelteon group compared to the placebo group. |
The average number of hours of sleep, and the number of awakenings as measured by actigraphy, which is a wearable accelerometer that is validated to assess sleep quality. This will be recorded during the ICU stay starting from the time of enrollment until discharge from the ICU, up to 30 days maximum. |
During the entire ICU stay upon enrollment up to 30 days. |
|
Secondary |
Richards-Campbell Sleep Questionnaire (RCSQ) scores in ramelteon group compared to the placebo group. |
Richards-Campbell Sleep Questionnaire is a validated sleep survey using visual analog scale (VAS) filled out by the subject, which comprises of 5 questions with scores ranging from minimum 0 to maximum 100, which is computed as an average of the 5 subscales. The higher score indicates worse sleep quality. |
Until discharge or up to 30 days of hospitalization, whichever is sooner. |
|
Secondary |
Telephone Interview for Cognitive Status (TICS) scores at 1-, 3-, and 6-month post ICU discharge in ramelteon group compared to the placebo group. |
Telephone Interview for Cognitive Status is a validated phone-based assessment of cognitive status. The score ranges from 0 to 40, which is computed as a sum of subscales. The lower score indicates worse degree of cognitive impairment. |
At one, three, and six month post ICU discharge. |
|
Secondary |
EQ-5D (Euro Quality of life-5 Dimensions) scores at 1-, 3-, and 6-month post ICU discharge in ramelteon group compared to the placebo group. |
Euro Quality of life-5 Dimensions is a health related quality of life questionnaire that is telephone-based. It is comprised of 5 health related quality of life questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and each question is in multiple-choice format. The score ranges from 5 to 25, which is computed as a sum of each subscale. The higher scores indicating worse health-related quality of life assessment. |
At one, three, and six month post ICU discharge. |
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