Cerebral Autoregulation and COVID-19

NCT04930874 | Terminated DMC

• 1 other identifier: CA-COVID 196/10-6-2021
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess cerebral autoregulation by near-infrared spectroscopy (NIRS) in patients with severe coronavirus disease 19 (COVID-19). Results on COVID-19 participants will be compared with prior results of patients with septic shock and cardiac arrest, who participated in NCT03649633 and NCT02790788, respectively.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Pneumonia

Keywords

COVID-19; Cerebrovascular circulation; Spectroscopy, Near-Infrared

Outcome Measures

Primary Outcomes (2)

• Cerebral autoregulation

  The tissue oxygenation index of the frontal cortex will be determined (at a rate of 180 measurements / min) while increasing MAP from a minimum of 65-75 mmHg to a maximum of 90-100 mmHg by changing the vasopressor infusion rate. Cooncurrent changes in MAP will also be recorded. Subsequently, linear regression between MAP and the Tissue Oxygenation Index will be performed. A Pearson correlation coefficient of \>0.3 will be considered as "absence" of autoregulation of the cerebral vasculature.

  Days 1-4 of ICU admission

• Cerebral blood flow

  Cerebral blood flow at MAP 65-75 mmHg and MAP 90-100 mmHg by determination of the blood flow index.

  Days 1-4 of ICU admission

Secondary Outcomes (6)

• Neurologic failure free days

  Days 1-60 after ICU admission

• Ventilator free days

  Days 1-60 after ICU admission

• Survival to hospital discharge and neurological outcome

  Days 1-60 after ICU admission

• Survival to hospital discharge and neurological outcome

  Days 1-60 after ICU admission

• Survival to hospital discharge and neurological outcome

  Days 1-60 after ICU admission

Study Arms (1)

ICU patients with COVID-19

EXPERIMENTAL

NIRS monitoring will be performed for approximately 90 minutes at 2 mean blood pressure levels (MAP, ie 65-70 mmHg and 95-100 mmHg) within 12-48 hours and 60-84 hours after admission to the ICU for severe COVID-19 infection. Autoregulation will be assessed using Tissue Oxygenation Index values and mean arterial pressure values in a regression analysis and will be considered sufficient if the relative Pearson correlation coefficient is less than 0.3. Cerebral blood flow will be assessed by blood flow index determination after intravenous infusion of 5 mg indocyanine.

Other: NIRS (Near-Infrared Spectroscopy)

Interventions

NIRS (Near-Infrared Spectroscopy) OTHER

NIRS assessment of cerebral autoregulation and cerebral blood flow

ICU patients with COVID-19

Eligibility Criteria

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

You may qualify if:

• Admission to ICU and endotracheal intubation/mechanical ventilation for severe COVID-19 infection

You may not qualify if:

• Age \<18 years
• Pregnancy
• Patients with a terminal underlying disease who are unlikely to survive until discharge from the hospital
• Patients with acquired immunodeficiency and ("pre-COVID") lymphocyte Cluster Differentiation 4+ count \<50 / μL
• Patients with COVID-19 who have been transferred from another hospital
• Patients with a history of allergic reaction
• Use of prone position to facilitate mechanical ventilation
• Absence of signed informed consent from a first degree relative

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Department of Intensive Care Medicine Evaggelismos General Hospital

Athens, Attica, 10675, Greece

Location

Related Publications (17)

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MeSH Terms

Conditions

COVID-19

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Spyros D Mentzelopoulos, MD, Professor

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Anastasia D Kotanidou, MD, Professor

  National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Medicine, National and Kapodistrian University of Athens Medical School

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 18, 2021
• Study Start: June 22, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)