Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

NCT02069353 | Terminated Results

• 1 other identifier: PRO13060260
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Cardiac arrest; Neurological injury; Seizures; Spreading depolarizations; Cerebral hypoperfusion; Brain tissue hypoxia

Outcome Measures

Primary Outcomes (3)

• Spreading Depolarizations

  Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

• 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

• Cerebral Hypoperfusion

  Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Secondary Outcomes (3)

• Clinically Significant Bleeding

  Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks

• Monitor-associated Infection

  Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks

• Device Malfunction

  Participants will be followed for the duration of invasive monitoring, an expected average of 5 days

Study Arms (1)

Cardiac arrest

EXPERIMENTAL

Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring.

Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA); Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)

Interventions

QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) DEVICE

Cardiac arrest

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

Cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Jonathan Elmer: lead
• Laerdal Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Heart Arrest; Trauma, Nervous System; Seizures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jonathan Elmer
• Organization: University of Pittsburgh

elmerjp@upmc.edu

412-647-9489

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Emergency Medicine

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 24, 2014
• Study Start: July 1, 2015
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Locations

US (1)