Trial Outcomes & Findings for Esmolol to Treat the Hemodynamic Effects of Septic Shock (NCT NCT02369900)
NCT ID: NCT02369900
Last Updated: 2021-06-28
Results Overview
The primary endpoint will be mean norepinephrine equivalent dose (mcg/kg/min) at 6 hours after onset of study drug. For the vasopressor vasopressin, the dose of vasopressin was multiplied by 2.5 in order to create a norepinephrine equivalent dose. For the vasopressor phenylephrine, the dose of phenylephrine was divided by 10 in order to create a norepinephrine equivalent dose.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
6 hours
Results posted on
2021-06-28
Participant Flow
Participant milestones
| Measure |
Esmolol Infusion
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Esmolol to Treat the Hemodynamic Effects of Septic Shock
Baseline characteristics by cohort
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
64 years
n=99 Participants
|
62 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
22 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 hoursThe primary endpoint will be mean norepinephrine equivalent dose (mcg/kg/min) at 6 hours after onset of study drug. For the vasopressor vasopressin, the dose of vasopressin was multiplied by 2.5 in order to create a norepinephrine equivalent dose. For the vasopressor phenylephrine, the dose of phenylephrine was divided by 10 in order to create a norepinephrine equivalent dose.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Need for Vasopressor Support, Measured as Mean Norepinephrine Equivalent Dose (mcg/kg/Min), at 6hr Time Point
|
0.30 mcg/kg/min
Standard Deviation 0.17
|
0.21 mcg/kg/min
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 12 and 24 hoursWhile the primary endpoint will be mean norepinephrine dose at 6h, we will also measure mean vasopressor dose in groups at 12h and 24h.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Overall Need for Vasopressor Support
12 hours
|
0.31 mcg/kg/min
Standard Deviation 0.19
|
0.17 mcg/kg/min
Standard Deviation 0.17
|
|
Overall Need for Vasopressor Support
24 hours
|
0.24 mcg/kg/min
Standard Deviation 0.19
|
0.16 mcg/kg/min
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 6 and 12 hoursWe will measure median heart rate at the 6 and 12h time points.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Heart Rates Between Groups
6 hours
|
92 beats per minutes
Interval 89.0 to 104.0
|
98 beats per minutes
Interval 89.0 to 110.0
|
|
Heart Rates Between Groups
12 hours
|
89 beats per minutes
Interval 79.0 to 105.0
|
96 beats per minutes
Interval 85.0 to 105.0
|
SECONDARY outcome
Timeframe: Duration of hospitalization, limit 180 daysTime to shock reversal (cessation of all vasopressors for at least 12h).
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Time to Shock Reversal
|
3.9 days
Interval 1.9 to 6.5
|
2.5 days
Interval 1.5 to 6.1
|
SECONDARY outcome
Timeframe: 6, 12, and 24 hoursPopulation: One patient in the standard care group was missing lactate levels at 6, 12, and 24 hours and one patient in the standard care group was missing a lactate level at 24 hours.
Median percent change from baseline lactate measured at the 6, 12, and 24 hour time points after study initiation between groups. Percent change was calculated by subtracting the later lactate from the baseline lactate and dividing the difference by the baseline lactate (i.e. (baseline lactate - 6h lactate)/baseline lactate).
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=21 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Lactate
6 hours
|
16.7 percent change from baseline
Interval 2.7 to 22.2
|
0 percent change from baseline
Interval -21.4 to 19.3
|
|
Lactate
12 hours
|
27.5 percent change from baseline
Interval 4.3 to 37.9
|
8.8 percent change from baseline
Interval -5.3 to 35.3
|
|
Lactate
24 hours
|
30.4 percent change from baseline
Interval 12.1 to 50.0
|
19.1 percent change from baseline
Interval -18.2 to 37.1
|
SECONDARY outcome
Timeframe: 12 and 24 hoursPopulation: Only patients on mechanical ventilation who were able to be attached to the VO2 machine and had data within the first 24 hours were included.
To analyze the difference in oxygen consumption between groups at 12 hours, 24 hours and over time for patients who were on mechanical ventilation at enrollment, VO2 measurements were compared (standardized by bodyweight in kilograms) over time (recorded every minute from the time of study drug administration over a period of at least 24 hours) between groups using mixed linear model accounting for repeated measures. Using an unadjusted model, mean differences at 12 hours, 24 hours and for differences in the overall trend over time were tested.
Outcome measures
| Measure |
Esmolol Infusion
n=6 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=9 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Oxygen Consumption (VO2)
12 hours
|
3.78 mL/kg/min
Interval 3.09 to 4.21
|
4.29 mL/kg/min
Interval 3.27 to 4.82
|
|
Oxygen Consumption (VO2)
24 hours
|
4.13 mL/kg/min
Interval 2.74 to 6.32
|
4.83 mL/kg/min
Interval 2.63 to 9.19
|
SECONDARY outcome
Timeframe: 12 and 24 hoursPopulation: Blood was not able to be drawn from all patients at all time points.
To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of interleukin-4 at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Interleukin-4
12 hours
|
0.027 pg/mL
Interval 0.007 to 0.096
|
0.023 pg/mL
Interval 0.018 to 0.069
|
|
Interleukin-4
24 hours
|
0.016 pg/mL
Interval 0.008 to 0.067
|
0.018 pg/mL
Interval 0.011 to 0.086
|
SECONDARY outcome
Timeframe: 12 and 24 hoursPopulation: Blood was not able to be drawn from all patients at all time points.
To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of interleukin-6 at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Interleukin-6
12 hours
|
62.3 pg/mL
Interval 22.5 to 190.5
|
78.3 pg/mL
Interval 45.8 to 153.4
|
|
Interleukin-6
24 hours
|
54.4 pg/mL
Interval 18.1 to 242.4
|
39.0 pg/mL
Interval 16.5 to 118.9
|
SECONDARY outcome
Timeframe: 12 and 24 hoursPopulation: Blood was not able to be drawn from all patients at all time points.
To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of interleukin-10 at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Interleukin-10
12 hours
|
3.5 pg/mL
Interval 2.2 to 8.6
|
5.4 pg/mL
Interval 1.9 to 13.0
|
|
Interleukin-10
24 hours
|
3.4 pg/mL
Interval 1.7 to 7.1
|
2.8 pg/mL
Interval 1.4 to 6.0
|
SECONDARY outcome
Timeframe: 12 and 24 hoursPopulation: Blood was not able to be drawn from all patients at all time points.
To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of TNF-alpha at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
TNF-alpha
12 hours
|
4.5 pg/mL
Interval 2.3 to 8.9
|
8.7 pg/mL
Interval 4.6 to 16.5
|
|
TNF-alpha
24 hours
|
4.4 pg/mL
Interval 2.8 to 6.9
|
7.5 pg/mL
Interval 4.9 to 12.9
|
SECONDARY outcome
Timeframe: 12 and 24 hoursPopulation: Blood was not able to be drawn from all patients.
To characterize effects of esmolol on inflammatory markers in patients with vasopressor-dependent septic shock, we compared log-transformed values of C-reactive protein at 12 and 24 hours and over time between groups using mixed linear model accounting for repeated measures and adjusting for pre-intervention levels.
Outcome measures
| Measure |
Esmolol Infusion
n=18 Participants
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 Participants
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
C-reactive Protein
12 hours
|
140.5 pg/mL
Interval 101.8 to 191.8
|
170.2 pg/mL
Interval 87.8 to 244.6
|
|
C-reactive Protein
24 hours
|
155.2 pg/mL
Interval 74.0 to 201.8
|
189.7 pg/mL
Interval 105.4 to 217.5
|
Adverse Events
Esmolol Infusion
Serious events: 4 serious events
Other events: 0 other events
Deaths: 6 deaths
Standard Care, Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Esmolol Infusion
n=18 participants at risk
Esmolol infusion for 24 hours. Esmolol will be titrated to a heart rate of 80 - 94 per minute, starting at 10mcg/kg/min and subsequently increasing every 20 minutes in increments of 10 mcg/kg/min (or slower at the discretion of the team) until target is achieved. The maximum allowed dose will be 300mcg/kg/min.
Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Esmolol
|
Standard Care, Saline
n=22 participants at risk
Standard care (no esmolol). Patients, irrespective of treatment group, will be managed at the discretion of the clinical team. BIDMC has internal guidelines for the management of septic shock which reflect the most recent 2012 Surviving Sepsis Campaign guidelines and are incorporated into the care of patients with septic shock in the ICUs
Saline
|
|---|---|---|
|
Cardiac disorders
Decrease in Cardiac Index
|
22.2%
4/18 • Number of events 4 • 24 hours
|
0.00%
0/22 • 24 hours
|
|
Cardiac disorders
Abnormal Heart Rhythym
|
5.6%
1/18 • Number of events 1 • 24 hours
|
0.00%
0/22 • 24 hours
|
|
General disorders
PEA arrest
|
5.6%
1/18 • Number of events 1 • 24 hours
|
0.00%
0/22 • 24 hours
|
Other adverse events
Adverse event data not reported
Additional Information
Michael N. Cocchi MD
Beth Israel Deaconess Medical Center
Phone: 617-754-2388
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place