Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02069353
• Other study ID #: PRO13060260
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 19, 2018

Study information

• Verified date: September 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)

• Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Jonathan Elmer	Laerdal Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spreading Depolarizations		Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Primary	Occult Seizures	Seizures detected by intracortical EEG but not surface EEG	Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Primary	Cerebral Hypoperfusion		Participants will be followed for the duration of invasive monitoring, an expected average of 5 days
Secondary	Clinically Significant Bleeding		Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Secondary	Monitor-associated Infection		Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks
Secondary	Device Malfunction		Participants will be followed for the duration of invasive monitoring, an expected average of 5 days