The COGCOV Study in ICU Patients

NCT04593069 | Completed

• 1 other identifier: COGCOV
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Respiratory Distress syndrome (ARDS) is a pulmonary systematic inflammatory response, leading to acute respiratory failure with hypoxia and/or hypercarbia. COVID-19 evokes a viral pneumonia, which may result in ARDS as well. It is not yet clear if COVID-19 disease behaves like the typical ARDS. Corona virus causes primarily deep hypoxia. Hypoxia, on its own, can lead to long term cognitive impairment. However, critical illness also affects long-term neurocognitive functioning. The investigators will be researching the possibility of long-term cognitive impairment in COVID-19 ICU patients, in comparison with reference values of a healthy population as well as the values measured in critically ill patients, admitted not only for respiratory reasons.

Conditions

Covid19; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Neurocognitive impairment measured by RBANS

  the Repeatable Battery for the Assessment of Neuropsychological Statusis (RBANS) is a neuropsychological test that provides information about 5 domains of cognition (1) immediate and (2) delayed memory, (3) attention, (4) visuospatial construction and (5) language) and provides a total score. It is a test that takes about 30 minutes and consists of twelve tests. These are: (1) List Learning, (2) Story Memory, (3) Figure Copy, (4) Line Orientation, (5) Picture Naming, (6) Semantic Fluency, (7) Digit Span, (8) Coding, (9) List Recall, (10) List Recognition, (11) Story Recall and (12) Figure Recall. According to the RBANS manual, the possible values for the RBANS scores at the item, domain, and scale level are 0 to 89, 40 to 154, and 40 to 160

  6 months after admission at the intensive care unit

Secondary Outcomes (2)

• Neurocognitive impairment measured by TMT

  6 months after admission at the intensive care unit

• Neurocognitive impairment by the short IQCODE

  6 months after admission at the intensive care unit

Study Arms (1)

COVID-19 patients

OTHER

Neurocognitive impairment in COVID-19 patients

Behavioral: Neurocognitive assessment

Interventions

Neurocognitive assessment BEHAVIORAL

6 months after admission to the intensive care unit of Ziekenhuis Oost-Limburg, the patients will be tested on cognitive impairment

COVID-19 patients

Eligibility Criteria

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

You may qualify if:

• Admitted to the intensive care unit of Ziekenhuis Oost-Limburg
• Being hospitalized between March 2020 and May 2020, and therefore being admitted 6 months prior to the study
• The reason of hospitalization was COVID-19 disease

You may not qualify if:

• No willingness to participate, and therefore not having signed the informed consent

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction

Interventions

Mental Status and Dementia Tests

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; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Dieter Mesotten, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: masking is not applicable for this study
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: All patients enrolled in the study will be contacted to answer additional questions regarding cognitive impairment

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: October 7, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

BE (1)