Trial Outcomes & Findings for Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock (NCT NCT02633358)
NCT ID: NCT02633358
Last Updated: 2019-08-07
Results Overview
Survival rate according to the number of participants alive in the 90 days after enrollment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
90 days after enrollment
Results posted on
2019-08-07
Participant Flow
Recruitment period: 2015 Jan. to 2018 Apr. Types of location: Cardiac intensive care units, China Medical University Hospital, Taichung, Taiwan
Participant milestones
| Measure |
Therapeutic Hypothermia
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-hypothermia
Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
54
|
|
Overall Study
COMPLETED
|
87
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock
Baseline characteristics by cohort
| Measure |
Therapeutic Hypothermia
n=87 Participants
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-Hypothermia
n=54 Participants
Control group for non-hypothermia. Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese in Taiwan
|
86 participants
n=5 Participants
|
54 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
87 participants
n=5 Participants
|
54 participants
n=7 Participants
|
141 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 days after enrollmentPopulation: Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group
Survival rate according to the number of participants alive in the 90 days after enrollment.
Outcome measures
| Measure |
Therapeutic Hypothermia
n=87 Participants
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-hypothermia
n=54 Participants
Control group for non-hypothermia.
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
|---|---|---|
|
Survival Rate - Number of Participants Alive
Non-survival
|
32 Participants
|
34 Participants
|
|
Survival Rate - Number of Participants Alive
Survival
|
55 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 90 days after enrollmentPopulation: Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group
Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death.
Outcome measures
| Measure |
Therapeutic Hypothermia
n=87 Participants
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-hypothermia
n=54 Participants
Control group for non-hypothermia.
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
|---|---|---|
|
Neurologic Outcome - Number of Participants
Favorable neurologic outcome
|
30 Participants
|
10 Participants
|
|
Neurologic Outcome - Number of Participants
Poor neurologic outcome
|
57 Participants
|
44 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: between 6 and 24 hours after enrollment.Population: Randomized divided to two groups including therapeutic hypothermia and non-hypothermia group
IL-6 level change
Outcome measures
| Measure |
Therapeutic Hypothermia
n=87 Participants
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-hypothermia
n=54 Participants
Control group for non-hypothermia.
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
|---|---|---|
|
Interleukin-6 - the Plasma Level of Participants
6 hours after enrollment
|
2064.1 pg/mL
Standard Error 178.2
|
2392.4 pg/mL
Standard Error 181.3
|
|
Interleukin-6 - the Plasma Level of Participants
24 hours after enrollment
|
914.5 pg/mL
Standard Error 187.8
|
5125.0 pg/mL
Standard Error 592.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: between 6 and 24 hours after enrollmentInterleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling
Outcome measures
| Measure |
Therapeutic Hypothermia
n=87 Participants
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-hypothermia
n=54 Participants
Control group for non-hypothermia.
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
|---|---|---|
|
Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants
6 hours after enrollment
|
169.1 pg/mL
Standard Error 7.6
|
188.1 pg/mL
Standard Error 14.2
|
|
Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants
24 hours after enrollment
|
207.8 pg/mL
Standard Error 14.6
|
319.7 pg/mL
Standard Error 24.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: between 6 and 24 hours after enrollmentCheck the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment
Outcome measures
| Measure |
Therapeutic Hypothermia
n=87 Participants
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
Therapeutic hypothermia: Therapeutic hypothermia
|
Non-hypothermia
n=54 Participants
Control group for non-hypothermia.
Anti-inflammatory effect of therapeutic hypothermia. The hypothesis is anti-inflammatory effect triggered by IL-6 trans-signaling
|
|---|---|---|
|
Soluble Interleukin-6 Receptor - the Plasma Level of Participants
6 hours after enrollment
|
40.6 ng/mL
Standard Error 1.6
|
37.9 ng/mL
Standard Error 1.6
|
|
Soluble Interleukin-6 Receptor - the Plasma Level of Participants
24 hours after enrollment
|
37.9 ng/mL
Standard Error 1.3
|
35.7 ng/mL
Standard Error 1.5
|
Adverse Events
Therapeutic Hypothermia
Serious events: 57 serious events
Other events: 0 other events
Deaths: 32 deaths
Non-Hypothermia
Serious events: 44 serious events
Other events: 0 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Therapeutic Hypothermia
n=87 participants at risk
Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius.
|
Non-Hypothermia
n=54 participants at risk
Adverse events including ventricular arrhythmia, active bleeding, death due to lower core temperature less than 32 degree Celsius.
|
|---|---|---|
|
Nervous system disorders
Severe cerebral disability
|
12.6%
11/87 • Number of events 11 • 90-day follow up
|
7.4%
4/54 • Number of events 4 • 90-day follow up
|
|
Nervous system disorders
Coma or vegetative state
|
16.1%
14/87 • Number of events 14 • 90-day follow up
|
11.1%
6/54 • Number of events 6 • 90-day follow up
|
|
Nervous system disorders
Brain death
|
36.8%
32/87 • Number of events 32 • 90-day follow up
|
63.0%
34/54 • Number of events 34 • 90-day follow up
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Da-Long Chen, director of cardiac intensive care unit
China Medical University Hospital, Taichung, Taiwan
Phone: 0952122027
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place