Detection of Cerebral Ischemia With a Noninvasive Neurometabolic Optical Monitor

NCT02983786 | Completed DMC

• 1 other identifier: 819681
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of the project are to evaluate a noninvasive monitor of brain metabolism and blood flow in critically ill humans. If validated, such a reliable noninvasive brain blood flow and metabolism monitor, by allowing physiologic and pharmacologic decisions based on real-time brain physiology, potentially will become an important tool for clinicians in their efforts to prevent additional brain tissue death in patients admitted with stroke, brain hemorrhage and traumatic brain injury.

Conditions

Traumatic Brain Injury; Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage; Acute Anoxic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• The outcome variable will be the degree of correlation of ThD (thermodilution) CBF with optical CBF (cerebral blood flow).

  Determine if the optical monitoring device's assessment of CBF is valid.

  12 days

Secondary Outcomes (1)

• The outcome variable will be whether the optical monitoring system detects an anaerobic condition based on specific criteria of low ThD CBF, low brain PO2(PbrO2), and high microdialysis lactate pyruvate ratio ( LPR).

  12 Days

Other Outcomes (1)

• The outcome variable will be a determination of characteristics of trends in systemic and neurophysiologic data which predict the later development of an anaerobic condition in the brain.

  12 days

Study Arms (1)

Non-Invasive Monitoring

One non-invasive optode patch will be placed adjacent to the area of invasive monitoring and the second patch will be placed contralaterally. (12 hrs. daily is chosen primarily for budgetary reasons). The information for the non-invasive technology will be compared to the invasive technology. ICG (Indocyanine Green) will be injected to derive absolute CBF and calibrate the DCS monitor to yield continuous absolute CBF. During each 12-hour monitoring session, for up to 14 days, the ICG will be injected at baseline(0.2 mg/kg,(4), every four hours (or less if signal is stable).

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

ICG will be injected to derive absolute CBF and calibrate the DCS monitor to yield continuous absolute CBF. During each 12-hour monitoring session, for up to 14 days, the ICG will be injected at baseline(0.2 mg/kg,(4), every four hours (or less if signal is stable).

Also known as: Indocyanine Green Injection

Non-Invasive Monitoring

Eligibility Criteria

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

Study Population

Inclusion criteria will be age greater than or equal to 18 years, the diagnosis of SAH, TBI, ICH, and/or PIAE after cardiac arrest (post cardiac arrest coma) with GCS less than or equal to 8 (coma- clinical indications for invasive neuromonitoring), endotracheal intubation, clinical indications for invasive neuromonitoring, and family/guardian informed consent.

You may not qualify if:

• coagulation or platelet problems which cannot be corrected based on clinical indications
• anatomic abnormalities in skull or brain tissue precluding appropriate placement of an invasive brain monitor
• ongoing CNS or scalp infection,
• allergy to indocyanine green dye
• pregnancy
• lactation or pumping breast milk for the purpose of feeding an infant
• increased bilirubin suggestive of cholestasis or biliary obstruction, (8) allergy to iodide
• (9) severity of injury which leads the team or family to conclude that further advance medical care would be futile and limitation of the level of support is requested.
• Woman of childbearing potential will be excluded by urine or serum pregnancy test prior to conducting any study related procedures. . There is not a risk of pregnancy during this study as comatose patients will be monitored 24 hours a day in Intensive Care Units which have full visibility of patients.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Ischemic Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• W. Andrew Kofke, MD

  University of Pennsylvania Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 6, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: May 25, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)