COVID-19 Brain Injury

Completed

• Conditions: Sars-CoV2; Ischemic Stroke; Intracerebral Hemorrhage; Severe Neurologic Injury; Status Epilepticus; Hemorrhagic Stroke; Subarachnoid Hemorrhage; Traumatic Brain Injury

• Registration Number: NCT04496076
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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 Timeline

• Study Start: 2020-04-02
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-03
• Primary Completion: 2021-03-31
• Status Verified: 2021-04
• Study Completion: 2021-05-31
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital Mortality	At hospital discharge, approximately 1 month
30-day mortality	30 days post-hospital discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States