Trial Outcomes & Findings for Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal (NCT NCT05575219)
NCT ID: NCT05575219
Last Updated: 2025-01-28
Results Overview
The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued. WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal. The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
128 participants
Primary outcome timeframe
from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
32
|
|
Overall Study
COMPLETED
|
96
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
n=96 Participants
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
n=32 Participants
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10 months
n=96 Participants
|
16.5 months
n=32 Participants
|
10.5 months
n=128 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=96 Participants
|
21 Participants
n=32 Participants
|
75 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=96 Participants
|
11 Participants
n=32 Participants
|
53 Participants
n=128 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
96 participants
n=96 Participants
|
32 participants
n=32 Participants
|
128 participants
n=128 Participants
|
|
Weight
|
7.515 kilograms
n=96 Participants
|
10.95 kilograms
n=32 Participants
|
8.418 kilograms
n=128 Participants
|
|
Primary Diagnosis
Cardiac Diagnosis
|
40 Participants
n=96 Participants
|
0 Participants
n=32 Participants
|
40 Participants
n=128 Participants
|
|
Primary Diagnosis
Respiratory Diagnosis
|
45 Participants
n=96 Participants
|
22 Participants
n=32 Participants
|
67 Participants
n=128 Participants
|
|
Primary Diagnosis
Neurologic Diagnosis
|
3 Participants
n=96 Participants
|
2 Participants
n=32 Participants
|
5 Participants
n=128 Participants
|
|
Primary Diagnosis
Sepsis Diagnosis
|
4 Participants
n=96 Participants
|
2 Participants
n=32 Participants
|
6 Participants
n=128 Participants
|
|
Primary Diagnosis
Hematology/Oncology Diagnosis
|
2 Participants
n=96 Participants
|
2 Participants
n=32 Participants
|
4 Participants
n=128 Participants
|
|
Primary Diagnosis
Other Diagnosis
|
2 Participants
n=96 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=128 Participants
|
PRIMARY outcome
Timeframe: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)Population: Data were not collected from 5 participants in the Usual care (without protocolized clonidine initiation) arm. Data were not collected from 2 participants in the Intervention (protocolized clonidine initiation) arm.
The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued. WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal. The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.
Outcome measures
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
n=91 Participants
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
n=30 Participants
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
|---|---|---|
|
Number of Participants With Withdrawal
|
33 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During time in Pediatric Intensive Care Unit (about 260 Hours)number of total hours on dexmedetomidine
Outcome measures
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
n=96 Participants
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
n=32 Participants
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
|---|---|---|
|
Hours on Dexmedetomidine
|
153.43 Hours
Interval 114.79 to 218.62
|
155.33 Hours
Interval 132.83 to 260.23
|
SECONDARY outcome
Timeframe: During time in Pediatric Intensive Care Unit (about 10 to 30 days)Population: Data were not collected for 8 participants in the Usual care (without protocolized clonidine initiation) arm.
number of days in the PICU
Outcome measures
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
n=88 Participants
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
n=32 Participants
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
|---|---|---|
|
Pediatric Intensive Care Unit (PICU) Length of Stay
|
13 Days
Interval 9.0 to 28.0
|
10.5 Days
Interval 8.75 to 16.25
|
SECONDARY outcome
Timeframe: During time in Pediatric Intensive Care Unit (about 24 days)Outcome measures
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
n=96 Participants
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
n=32 Participants
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
|---|---|---|
|
Dexmedetomidine Cost Per Kilogram During Hospitalization
|
19.98 dollars per kilogram
Interval 14.5 to 32.72
|
29.46 dollars per kilogram
Interval 20.19 to 47.64
|
SECONDARY outcome
Timeframe: During time in Pediatric Intensive Care Unit (about 24 days)Outcome measures
| Measure |
Usual Care (Without Protocolized Clonidine Initiation)
n=96 Participants
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
Clonidine (without protocolized initiation): Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
|
Intervention (Protocolized Clonidine Initiation)
n=32 Participants
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
Clonidine (protocolized initiation): - Observe participants without initiating clonidine with dexmedetomidine infusion time of 72-119 hours. To wean off dexmedetomidine, decrease the infusion by 25% of the starting dose every 6 hours.
* Begin clonidine at 1 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of 120-144 hours.
* Begin clonidine at 1.5 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion times of 145-167 hours.
* Begin clonidine at 2 mcg/kg enterally every 6 hours for participants with dexmedetomidine infusion time of \>/= 168 hours or with infusion time of 120-167 hours at doses \>/= 1.1 mcg/kg/min.
* If clonidine is started decrease the dexmedetomidine infusion by 25% of the starting dose 1 hour after each dose of clonidine until off (wean every 6 hours).
|
|---|---|---|
|
Clonidine Cost Per Kilogram During Hospitalization
|
0.06 cents per kilogram
Interval 0.03 to 0.14
|
0.05 cents per kilogram
Interval 0.02 to 0.1
|
Adverse Events
Usual Care (Without Protocolized Clonidine Initiation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention (Protocolized Clonidine Initiation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrea Leigh Heifner, MD
The University of Texas Health Science Center at Houston
Phone: 407-729-2972
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place