Trial Outcomes & Findings for Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure (NCT NCT02203019)
NCT ID: NCT02203019
Last Updated: 2020-03-02
Results Overview
Number of days patient requires mechanical ventilation
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2020-03-02
Participant Flow
Participant milestones
| Measure |
Propofol
Propofol will be administered for sedation.
Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Dexmedetomidine
Dexmedetomidine will be administered for sedation
Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure
Baseline characteristics by cohort
| Measure |
Propofol
n=19 Participants
Propofol will be administered for sedation.
Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Dexmedetomidine
n=17 Participants
Dexmedetomidine will be administered for sedation
Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
60.75 years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
BMI
|
30.1 kg/m2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
29.7 kg/m2
STANDARD_DEVIATION 8.2 • n=7 Participants
|
29.9 kg/m2
STANDARD_DEVIATION NA • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysNumber of days patient requires mechanical ventilation
Outcome measures
| Measure |
Propofol
n=19 Participants
Propofol will be administered for sedation.
Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Dexmedetomidine
n=17 Participants
Dexmedetomidine will be administered for sedation
Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
5 days
Interval 3.0 to 13.0
|
3 days
Interval 2.75 to 5.75
|
SECONDARY outcome
Timeframe: Up to 28 DaysNumber of days patient stays in the MICU
Outcome measures
| Measure |
Propofol
n=19 Participants
Propofol will be administered for sedation.
Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Dexmedetomidine
n=17 Participants
Dexmedetomidine will be administered for sedation
Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
|---|---|---|
|
Duration of MICU Stay
|
6 days
Interval 4.0 to 14.0
|
5 days
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Up to 28 DaysNumber of days the patient requires intravenous vasopressors
Outcome measures
| Measure |
Propofol
n=19 Participants
Propofol will be administered for sedation.
Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Dexmedetomidine
n=17 Participants
Dexmedetomidine will be administered for sedation
Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
|---|---|---|
|
Duration of Vasopressor Support
|
0 days
Interval 0.0 to 3.3
|
2 days
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 28 DaysNumber of patients who die within 28 days after randomization
Outcome measures
| Measure |
Propofol
n=19 Participants
Propofol will be administered for sedation.
Propofol: Propofol will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
Dexmedetomidine
n=17 Participants
Dexmedetomidine will be administered for sedation
Dexmedetomidine: Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis using a titration based on level of agitation.
Fentanyl: Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
|
|---|---|---|
|
Mortality
|
8 Participants
|
9 Participants
|
Adverse Events
Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place