COVID-19 Brain Injury

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT04496076

Collaborator

(none)

300

Enrollment

Location

13.9

Actual Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

Condition or Disease	Intervention/Treatment	Phase
Sars-CoV2 Severe Neurologic Injury Ischemic Stroke Hemorrhagic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage Traumatic Brain Injury Status Epilepticus

Detailed Description

COVID 19 pandemic has overwhelmed healthcare capacity in many regions around the world. As resources become more limited and we have to triage /ration ventilators, neurologically injured ICU patients without COVID 19 but with respiratory insufficiency may be triaged to no ventilator care due to their perceived or actual prognosis. This may lead to increased rates of withdrawal of care and mortality. Some neurologically injured ICU patients with respiratory insufficiency may be simultaneously infected with COVID 19. Their outcomes are completely unknown. Capturing data on the prevalence of limitation of care and prognosis in this patient population will provide important information towards ongoing efforts in patient care and resource utilization as we face the rapidly evolving COVID 19 pandemic. Given the expected strain on ICU resources and limitations in research in ICUs during COVID 19 pandemic, data capture/study design must be targeted and pragmatic. This study is designed to answer the most basic and important questions while minimizing the burden of data collection on already overloaded providers.

This study design is comprised of two components: Component 1- Prospective cohort prevalence study captures data related to treatments offered, limitations of care and patient outcome in 5 select primary neurological diagnoses requiring ICU care. Component 2- Case control study captures the same data elements in the same patient populations during the 3 months prior COVID 19 pandemic (Sept - Dec, 2019).

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Severe Neurologic Injury Outcomes During COVID-19 Crisis

Actual Study Start Date :

Apr 2, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

May 31, 2021

Outcome Measures

Primary Outcome Measures

In-hospital Mortality [At hospital discharge, approximately 1 month]
30-day mortality [30 days post-hospital discharge]

Secondary Outcome Measures

Limitations of patient care- Frequency of care not being provided [During In-hospital course, up to 1 month]
Care treatment such as ventilator use, intubation, and/or tracheostomy
Limitations of patient care- Conversion of DNR/DNI/CMO status [During In-hospital course, up to 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients greater than or equal to 18
Patients who require critical care with primary diagnoses of: Acute ischemic stroke (AIS), acute intracerebral hemorrhage (ICH), acute subarachnoid hemorrhage (SAH), acute traumatic brain injury (TBI), status epilepticus (SE) patients requiring critical care

Exclusion Criteria:

Patients under the age of 18 years old
Pre-existing Do Not Resuscitate (DNR), Do Not Intubate (DNI), or Comfort Measures Only (CMO) status prior to acute hospitalization
Neurologically morbid-bound on hospital arrival (bilateral fix/dilated pupils, catastrophic bleed/TBI) and likely to progress to brain death within 48 hrs