Cardiac Arrest
Conditions
Keywords
Cardiac arrest, Return of Spontaneous Circulation (ROSC), IntraVascular Temperature Management (IVTM), Therapeutic Hypothermia, Japan
Brief summary
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC) patients in Japan. The objective of this study is to verify that therapeutic hypothermia performed by intravascular cooling using the investigational device (IVTM) can control body temperature appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.
Interventions
Induced therapeutic hypothermia post cardiac arrest
Sponsors
Asahi Kasei Medical Co., Ltd.
ZOLL Circulation, Inc., USA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Non-traumatic in-hospital or out-of-hospital cardiac arrest 2. Unwitnessed cardiac arrest (Ventricular fibrillation), or witnessed cardiac arrest (ventricular fibrillation, pulseless electrical activity, asystole within 15 minutes following onset) 3. Patient is at least 20 years of age and less than 80 years of age with consent is given 4. In the judgement of an investigator or sub-investigator, the patient is unable to follow verbal instructions 5. Therapeutic hypothermia using the investigational device can be initiated within six hours of Return of Spontaneous Circulation (ROSC) 6. Written consent can be obtained from a legally acceptable representative
Exclusion criteria
1. Traumatic cardiac arrest (blunt trauma, penetrating trauma, burns, exsanguination, suffocation, smoke inhalation, near drowning, etc) 2. Accidental hypothermia with core body temperature less than 35.0°C 3. Pregnant or of child bearing potential 4. Patient has given or indicated a Do Not Resuscitate (DNR) order 5. Femoral venous access is contraindicated by previous surgey, medical history, anatomy or the like 6. An inferior vena cava filter is in place 7. Patient has severe bleeding (Pulmonary hemorrhage, gastrointestinal hemorrhage, etc.) 8. Intracranial hemorrhage as confirmed by CT scanning 9. Hemodynamic instability despite use of vasopressor agents and cardiac stimulants 10. Heparin hypersensitivity 11. Serious systemic infectious diseases (sepsis, etc.) 12. Platelet count less than 30,000/mm3 13. Serious hepatic dysfunction 14. Serious renal impairment 15. Using percutaneous cardiopulmonary support (PCPS) 16. Using continuous hemodiafiltration (CHDF) 17. Therapeutic hypothermia has been otherwise implemented between ROSC and the start of the study (excluding the rapid infusion of non-glucose-containing cold electrolyte fluid, or non-glucose-containing cold plasma volume expander) 18. The patient's core body temperature cannot be monitored 19. Currently participating in another clinical trial or has participated in another clinical trial within the past six months 20. in the judgement of an investigator or sub-investigator, participation in this clinical trial is inappropriate for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Core temperature achievement ratio | Baseline and 3 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Performance Category (CPC) | Baseline and 14 days | — |
| Modified Rankin Scale (mRS) | Baseline and 14 days | — |
| Change in body temperature | Baseline and 96 hours | — |
| Cooling speed | Baseline and 3 hours | — |
| Safety | Baseline vs. 2 days | Incidence of adverse events at 2 days compared to baseline. |
Countries
Japan
Outcome results
None listed