cardiac arrest
Conditions
Interventions
Cooling and maintaining mild hypothermia using an automated peritoneal lavage
system.
Sponsors
Velomedix, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. cardiac arrest (in-hosptial or out-of hospital) with return of spontaneous circulation 2. myocardial infarction (18-85 years): STEMI
Exclusion criteria
Exclusion criteria: 1. Subject is known to be pregnant; 2. Subject is obeying commands; 3. Subject has a known history of abdominal surgery, peritonitis, or currently undergoing regular peritoneal dialysis; 4. Subject has a known history of severe chronic obstructive pulmonary disorder (COPD) (i.e., requires supplemental home oxygen); 5. Subject has a known anatomic abnormality that in the physician*s opinion will create additional risk when treating the patient (i.e., profound obesity, abdominal aortic aneurysm, abdominal wall hernia, spinal deformity, etc.); 6. Subject has a known severe neurological dysfunction evident prior to the presenting acute event; 7. Subject has known significant concomitant illness (other than cardiac arrest) with a life expectancy of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (composite of new-onset serious adverse event(s), feasibility, side effects, and efficacy (infarct size). | — |
Secondary
| Measure | Time frame |
|---|---|
| * CA subgroup (with or without STEMI): Percentage of subjects with good neurologic outcome (Glasgow Outcome Score of 4 or 5] at any time during their hospital stay) and at 6 months * STEMI subgroup (with or without CA): Myocardial infarct size at 14 days (± 3 days) post-procedure as measured by Tc99m Sestamibi single photon emission computed tomography (SPECT). * All cause mortality through 6 months post-procedure. * Device success defined as the capability of the device to decrease subject core temperature to 34°C within 30 minutes of treatment. * STEMI subgroup (without CA): MACE at 30 days (± 7 days) as defined by death or non-fatal reinfarction or ischemia-driven TVR. | — |
Countries
Netherlands
Outcome results
None listed