Clinical trial NCT02069353: Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest
Official title: Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Neurological injury
Seizures
Spreading depolarizations
Cerebral hypoperfusion
Brain tissue hypoxia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Laerdal Foundation
First posted: 2014-02-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat.

In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and "spreading depolarizations" will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.


Eligibility criteria: Inclusion Criteria:

* High risk survivors of cardiac arrest
* Decision by potential subject's clinical team to use our institutional standard invasive, multimodal neurologic monitoring for post-arrest care

Exclusion Criteria:

* None

Primary outcomes:
measure: Spreading Depolarizations
timeFrame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
measure: Occult Seizures
timeFrame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
measure: Cerebral Hypoperfusion
timeFrame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Secondary outcomes:
measure: Clinically Significant Bleeding
timeFrame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
measure: Monitor-associated Infection
timeFrame: Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
measure: Device Malfunction
timeFrame: Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: