N/A
N=141
Anti-inflammatory Effect of Therapeutic Hypothermia in Out-hospital Cardiac Arrest Patients With Cardiogenic Shock
Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT02633358 ↗Enrolled (actual)
141
Serious AEs
71.6%
Results posted
Jul 2019
Primary outcome: Primary: Survival Rate - Number of Participants Alive — 55; 20; 32; 34 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therapeutic hypothermia group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- China Medical University Hospital
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Rate - Number of Participants Alive |
55; 20; 32; 34 | <0.001 sig |
| SECONDARY Neurologic Outcome - Number of Participants |
30; 10; 57; 44 | 0.04 sig |
Summary
Acute myocardial infarction complicated with cardiogenic shock trigger IL-6, the strong inflammatory response, result in multiple organ failure, even death.
While therapeutic hypothermia,to expect the possibility of anti-inflammatory effect via IL-6 bi-phasic effect and IL-10 , to improve the multiple organ failure, to increase survival rate and well cerebral performance.
Eligibility Criteria
Inclusion Criteria
- Age between 18-100 years
- Cardiogenic sock including initial lactate level >18 mg/dL, necessary of vasopressor to keep mean artery pressure >65mmHg after adequate fluid supply, and signs of reduced cardiac output including disturbance consciousness, cold limbs, decreased urine output, acute pulmonary congestion and so on.
Exclusion Criteria
- Patient or family refuse
- Metastatic cancer
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02633358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.