Delirium
Conditions
Keywords
prevention; delirium; in-patients; melatonin,
Brief summary
A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.
Detailed description
This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus. Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged. Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.
Interventions
DRUGMelatonin
5 mg Melatonin nightly, beginning within 24 hours of admission
OTHERPlacebo
Blue capsule matching the melatonin arm
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatient admission to a general internal medicine service
Exclusion criteria
* expected lifespan or length of stay ≤ 48 hours * Non-English speaking * Already taking melatonin or ramelteon at the time of randomization * Presence of delirium at the time of randomization * Unable to take oral medications * Subject or proxy unable to provide informed consent within 18 hours of invitation or 24 hours of admission * ALT or AST (Liver function tests) \> 3 times the upper limit of normal * Taking warfarin, nifedipine or fluvoxamine * Allergy to melatonin * Unable to recall 3 words after distraction by naming the days of the week backwards beginning with Sunday
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium | length of hospitalization, not to exceed 14 days | Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | from day of admission to completion of acute care, not to exceed 30 days | Length of stay is defined as the total time hospitalized for the acute illness (in days). |
| Days Utilizing Restraints | length of hospitalization, not to exceed 14 days | Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization. |
| Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization. | length of hospitalization, not to exceed 14 days | Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Melatonin 5 mg Melatonin nightly, beginning within 24 hours of admission
Melatonin | 136 |
| Cellulose Microcrystylline Blue capsule matching the melatonin arm
Melatonin | 141 |
| Total | 277 |
Baseline characteristics
| Characteristic | Melatonin | Total | Cellulose Microcrystylline |
|---|---|---|---|
| Age, Continuous | 77.98 years STANDARD_DEVIATION 8.53 | 78.49 years STANDARD_DEVIATION 8.46 | 78.99 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 267 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 32 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) White | 117 Participants | 236 Participants | 119 Participants |
| Region of Enrollment United States | 136 participants | 277 participants | 141 participants |
| Sex: Female, Male Female | 78 Participants | 145 Participants | 67 Participants |
| Sex: Female, Male Male | 58 Participants | 132 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 141 |
| other Total, other adverse events | 5 / 136 | 1 / 141 |
| serious Total, serious adverse events | 0 / 136 | 0 / 141 |
Outcome results
Primary
Delirium
Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization.
Time frame: length of hospitalization, not to exceed 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Melatonin | Delirium | 2 Participants |
| Cellulose Microcrystylline | Delirium | 8 Participants |
Secondary
Days Utilizing Restraints
Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization.
Time frame: length of hospitalization, not to exceed 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Days Utilizing Restraints | 0 days |
| Cellulose Microcrystylline | Days Utilizing Restraints | 0 days |
Secondary
Length of Hospital Stay
Length of stay is defined as the total time hospitalized for the acute illness (in days).
Time frame: from day of admission to completion of acute care, not to exceed 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Melatonin | Length of Hospital Stay | 4.58 days | Standard Deviation 2.91 |
| Cellulose Microcrystylline | Length of Hospital Stay | 4.71 days | Standard Deviation 3.7 |
Secondary
Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.
Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization.
Time frame: length of hospitalization, not to exceed 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization. | 0 number of doses per days of hospitalizat |
| Cellulose Microcrystylline | Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization. | 0 number of doses per days of hospitalizat |