Determination of Acute Encephalopathy Predictors in Patients With COVID-19

NCT04405544 | Completed

• 1 other identifier: NMSC-01-20
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The SARS-CoV-2 infection was detected in December 2019 in Wuhan City, China. The infection affects all age groups, although childhood is the lowest proportion of those affected. The main clinical manifestations that require hospitalization of infected patients are SARS pneumonia, which may require treatment in the intensive care unit (27%) and its progression into acute respiratory distress syndrome (67%) with life-threatening conditions in almost 25% of patients diagnosed with "SARS-CoV-2 infection". Nervous system damage with SARS-CoV-2 infection has been practically not investigated, but neurological disorders have been reported in 36% of these patients. Finally, the mortality rate associated with the new virus is high in patients who require treatment in intensive care units (62% of cases). Therefore, we are conducting a prospective study to identify acute encephalopathy predictors in patients with COVID-19.

Conditions

Encephalopathy; COVID

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who have developed encephalopathy

  The percentage of patients who have developed encephalopathy

  10 days

Study Arms (2)

Main

OTHER

patients with COVID-19 and Acute Encephalopathy

Diagnostic Test: CT-scan; Diagnostic Test: EEG; Diagnostic Test: EP; Diagnostic Test: Pulse oximetry; Diagnostic Test: Blood tests

Control

OTHER

patients with COVID-19 without Acute Encephalopathy

Diagnostic Test: CT-scan; Diagnostic Test: EEG; Diagnostic Test: EP; Diagnostic Test: Pulse oximetry; Diagnostic Test: Blood tests

Interventions

CT-scan DIAGNOSTIC_TEST

chest CT-scan

Control; Main

EEG DIAGNOSTIC_TEST

Electroencephalography

Control; Main

EP DIAGNOSTIC_TEST

Evoked potential

Control; Main

Pulse oximetry DIAGNOSTIC_TEST

Pulse oximetry

Control; Main

Blood tests DIAGNOSTIC_TEST

Blood tests

Control; Main

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18 to 60 years
• Out-of-hospital pneumonia with confirmed pulmonary tissue infiltration according to CT with changes corresponding to the average and high probability of coronavirus pneumonia (4-5 levels by CO-RADS classification) and the loss of more than 25% of one of the lungs.
• The patient has read the information sheet and signed the informed consent form.

You may not qualify if:

• Negative PCR test for coronavirus infection.
• The presence in the anamnesis of data for myocardial infarction or stroke.
• Verified thrombophilia.
• Pregnancy.
• Patients with malignant tumors (including anamnesis), including postoperative period in the background of chemo and/or radiation therapy.
• Acute stroke.
• Dropout Criteria:
• Patient's refusal to participate further in the study.
• Negative PCR result for coronavirus infection.

Sponsors & Collaborators

• State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia: lead

Study Sites (1)

N.I. Pirogov National Medical and Surgical Center

Moscow, 105203, Russia

Location

Related Publications (2)

• Slooter AJC, Otte WM, Devlin JW, Arora RC, Bleck TP, Claassen J, Duprey MS, Ely EW, Kaplan PW, Latronico N, Morandi A, Neufeld KJ, Sharshar T, MacLullich AMJ, Stevens RD. Updated nomenclature of delirium and acute encephalopathy: statement of ten Societies. Intensive Care Med. 2020 May;46(5):1020-1022. doi: 10.1007/s00134-019-05907-4. Epub 2020 Feb 13. No abstract available.

  PMID: 32055887 BACKGROUND

• Vinogradov OI, Ogarkova TK, Shamtieva KV, Alexandrov PV, Mushba AV, Kanshina DS, Yakovleva DV, Surma MA, Nikolaev IS, Gorst NK. Predictors of Acute Encephalopathy in Patients with COVID-19. J Clin Med. 2021 Oct 20;10(21):4821. doi: 10.3390/jcm10214821.

  PMID: 34768339 DERIVED

MeSH Terms

Conditions

Brain Diseases

Interventions

Tomography, X-Ray Computed; Electroencephalography; Oximetry; Hematologic Tests

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Diagnostic Techniques, Neurological; Electrodiagnosis; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Oleg I Vinogradov, MD, PhD

  N.I. Pirogov National Medical and Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: May 22, 2020
• Primary Completion: July 22, 2020
• Study Completion: October 29, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)