Trial Outcomes & Findings for Cycling of Sedative Infusions in Critically Ill Pediatric Patients (NCT NCT01333059)
NCT ID: NCT01333059
Last Updated: 2019-01-15
Results Overview
Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
From date of randomization until the date of discharge from PICU, assessed up to 1 month
Results posted on
2019-01-15
Participant Flow
Participant milestones
| Measure |
Experimental Group
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Experimental Group
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Protocol Violation
|
3
|
0
|
Baseline Characteristics
Cycling of Sedative Infusions in Critically Ill Pediatric Patients
Baseline characteristics by cohort
| Measure |
Experimental Group
n=14 Participants
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
n=11 Participants
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
0.24 years
n=5 Participants
|
.20 years
n=7 Participants
|
0.22 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of discharge from PICU, assessed up to 1 monthPopulation: In October of 2012, the DSMB unanimously voted to close this study due to safety concerns and inactivity. The Board noted that recruitment goals had not been met and statistical analysis could not be made with current data.
Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.
Outcome measures
| Measure |
Experimental Group
n=14 Participants
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
n=11 Participants
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
Duration of Mechanical Ventilation Days
|
10.14 days
Standard Deviation 5.55
|
5.82 days
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: From date of randomization until the date of discharge from PICU, assessed up to 1 monthPopulation: In October of 2012, the DSMB unanimously voted to close this study due to safety concerns and inactivity. The Board noted that recruitment goals had not been met and statistical analysis could not be made with current data.
Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.
Outcome measures
| Measure |
Experimental Group
n=14 Participants
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
n=11 Participants
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
PICU Length of Stay
|
13.93 days
Standard Deviation 7.49
|
9.82 days
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: From date of hospital admission to date of hospital discharge, assessed up to 6 weeksPopulation: In October of 2012, the DSMB unanimously voted to close this study due to safety concerns and inactivity. The Board noted that recruitment goals had not been met and statistical analysis could not be made with current data
Participants will be followed for an expected average of 7 days in PICU and 10 days of hospitalization. This secondary endpoint is to be evaluated every six months.
Outcome measures
| Measure |
Experimental Group
n=14 Participants
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
n=11 Participants
In this arm, midazolam and fentanyl were administered during cycling.
At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.
Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
Hospital Length of Stay
|
25.21 days
Standard Deviation 16.69
|
20.82 days
Standard Deviation 17.80
|
Adverse Events
Experimental Group
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental Group
n=14 participants at risk
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
n=11 participants at risk
In this arm, midazolam and fentanyl were administered during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
Immune system disorders
Graft vs Host Disease
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
Other adverse events
| Measure |
Experimental Group
n=14 participants at risk
In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol.
|
Control Group
n=11 participants at risk
In this arm, midazolam and fentanyl were administered during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol.
|
|---|---|---|
|
Surgical and medical procedures
FiO2 increased
|
50.0%
7/14 • Number of events 8
|
18.2%
2/11 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place