Trial Outcomes & Findings for Pilot - Peri-operative Beta Blockade (NCT NCT02746575)
NCT ID: NCT02746575
Last Updated: 2020-01-30
Results Overview
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Before surgery and Immediately after surgery (on the day of surgery)
Results posted on
2020-01-30
Participant Flow
Participant milestones
| Measure |
Treatment
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
metoprolol
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Treatment
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
metoprolol
|
|---|---|
|
Overall Study
Surgery cancelled or time chaned
|
13
|
|
Overall Study
Received epidural
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Bradycardia/hypotension
|
9
|
|
Overall Study
Study paused
|
8
|
|
Overall Study
put on beta-blocker
|
3
|
|
Overall Study
type of surgery
|
1
|
|
Overall Study
typ of surgery
|
1
|
|
Overall Study
PI unavailable
|
1
|
|
Overall Study
Unknown history of CVA
|
1
|
Baseline Characteristics
Pilot - Peri-operative Beta Blockade
Baseline characteristics by cohort
| Measure |
Treatment
n=20 Participants
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
metoprolol
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before surgery and Immediately after surgery (on the day of surgery)Population: Only patients with complete hscTnI data were inlcuded
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Outcome measures
| Measure |
Treatment
n=18 Participants
Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
metoprolol
|
|---|---|
|
Difference in hscTnI Values
Preoperative visit
|
3.4 ng/L
Interval 2.0 to 4.8
|
|
Difference in hscTnI Values
Day of surgery
|
2.8 ng/L
Interval 2.3 to 4.4
|
Adverse Events
Treatment
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
Principal Investigator
Washington University
Phone: 7737022544
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place