Delirium
Conditions
Keywords
delirium, pediatrics, critical care, quetiapine
Brief summary
This study is designed to assess the safety and efficacy of quetiapine as treatment for pediatric delirium.
Detailed description
Many children in the ICU become confused, due to their underlying illness or treatment effects. The medical term for this confusion is delirium. In adults, a medication called quetiapine has been effective in treating delirium. This is considered an off label use as the FDA has not approved quetiapine for this indication. Pediatricians have been using quetiapine to treat delirium in children as well, but there is currently no data proving that it is effective in children. This study is being done to determine if quetiapine is effective for the treatment of ICU delirium in children.
Interventions
DRUGquetiapine
Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
OTHERPlacebo
Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
\- Any patient in the PICU aged 1 year to 21 years old who is diagnosed with delirium
Exclusion criteria
* Age \<1 * Richmond Agitation Sedation Scale (RASS) score of -4 or -5 (deeply sedated or unarousable). * current treatment for alcohol withdrawal * hepatic encephalopathy * pregnancy * diagnosis of major depressive disorder or bipolar disorder * diagnosis of movement disorder * diagnosis of diabetic ketoacidosis * baseline QTc \>500 milliseconds * non-English speaking subjects and/or parent/guardian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Resolution of Delirium | Within the first 10 days after study enrollment | Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium \[CAPD\]). If delirium did not resolve within the 10 day period, this defaults to 10 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total ICU Days With Delirium | Within 10 days after study enrollment | Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Delirium Severity | Baseline and 3 days of study drug initiation | Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores. |
Countries
United States
Participant flow
Recruitment details
Six participants were enrolled over 22 months between March 2015 and December 2016. The first participant was enrolled in March 2015 and the last participant was enrolled in December 2015.
Participants by arm
| Arm | Count |
|---|---|
| Quetiapine A randomized group will receive quetiapine as treatment for delirium.
Quetiapine: Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine. | 3 |
| Placebo A randomized group will receive placebo, and not quetiapine.
Placebo: Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo. | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Quetiapine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4 years | 3 years | 3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 1 / 3 |
Outcome results
Primary
Time to First Resolution of Delirium
Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium \[CAPD\]). If delirium did not resolve within the 10 day period, this defaults to 10 days.
Time frame: Within the first 10 days after study enrollment
Population: All participants are included in analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine | Time to First Resolution of Delirium | 8 days |
| Placebo | Time to First Resolution of Delirium | 7 days |
Secondary
Total ICU Days With Delirium
Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.
Time frame: Within 10 days after study enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine | Total ICU Days With Delirium | 8 days |
| Placebo | Total ICU Days With Delirium | 7 days |
Other Pre-specified
Change in Delirium Severity
Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores.
Time frame: Baseline and 3 days of study drug initiation
Population: Change in CAPD score from baseline to day 3. A decrease in total score implies an improvement in delirium. An increase in total score implies worsening delirium.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Quetiapine | Change in Delirium Severity | 1 units on a scale |
| Placebo | Change in Delirium Severity | 0 units on a scale |