Trial Outcomes & Findings for The Impact of Ramelteon on Sleep and Delirium in Patients Who Undergo Pulmonary Thromboendarterectomy (PTE) Surgery (NCT NCT02691013)

Results Overview

Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.

Recruitment status

UNKNOWN

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Twice daily for up to 10 days

Results posted on

2022-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo	Ramelteon Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon
Overall Study STARTED	61	59
Overall Study COMPLETED	58	59
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo	Ramelteon Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=58 Participants Patients will receive a Placebo tablet every evening. Placebo	Ramelteon n=59 Participants Patients will receive Ramelteon 8mg every evening. Ramelteon	Total n=117 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=58 Participants	0 Participants n=59 Participants	0 Participants n=117 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=58 Participants	39 Participants n=59 Participants	78 Participants n=117 Participants
Age, Categorical >=65 years	19 Participants n=58 Participants	20 Participants n=59 Participants	39 Participants n=117 Participants
Age, Continuous	56.1 years STANDARD_DEVIATION 15.8 • n=58 Participants	58.1 years STANDARD_DEVIATION 14.1 • n=59 Participants	57.1 years STANDARD_DEVIATION 14.9 • n=117 Participants
Sex: Female, Male Female	29 Participants n=58 Participants	30 Participants n=59 Participants	59 Participants n=117 Participants
Sex: Female, Male Male	29 Participants n=58 Participants	29 Participants n=59 Participants	58 Participants n=117 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	58 participants n=58 Participants	59 participants n=59 Participants	117 participants n=117 Participants

PRIMARY outcome

Timeframe: Twice daily for up to 10 days

Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo	Ramelteon n=59 Participants Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon
Duration of Delirium	16 hours Interval 10.0 to 29.0	24 hours Interval 14.0 to 37.0

PRIMARY outcome

Timeframe: Daily for up to 10 days

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Twice daily for up to 10 days

Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo	Ramelteon n=59 Participants Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon
Number of Participants With Delirium	22 Participants	19 Participants

SECONDARY outcome

Timeframe: 10 days

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of hospital admission

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo	Ramelteon n=59 Participants Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon
Length of Hospital Stay	12 days Interval 10.0 to 14.0	12 days Interval 10.0 to 16.0

SECONDARY outcome

Timeframe: Duration of hospital admission

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants Patients will receive a Placebo tablet every evening starting the night prior to the procedure for a maximum of 7 nights total. Placebo	Ramelteon n=59 Participants Patients will receive Ramelteon 8mg every evening starting the night prior to the procedure for a maximum of 7 nights total. Ramelteon
Length of ICU Stay	4 days Interval 3.0 to 5.0	4 days Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: 3 days

Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days

Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Ramelteon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Owens

University of California San Diego

Phone: 858-657-5258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place