The COGCOV Study in ICU Patients

Covid19 Clinical Trial

— COGCOV  

Official title:

Long-term Cognitive Impairment in ICU Patients, Admitted for COVID-19 Pneumonia: a Single Centre, Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593069
• Other study ID #: COGCOV
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: April 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators will conduct a single centre, prospective cohort study. COVID-19 patients from the Ziekenhuis Oost-Limburg cohort will be contacted by phone 6 months after admission at the ICU. Patients will be asked to participate in a study surrounding long term symptoms of COVID-19. When consent is given by the patiënt, the experimenter will conduct a short questionnaire over the phone with the patient or relative that is present at the time of the call. If the participant is fluent in Dutch, the experimenter will ask permission to visit their home to conduct more testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurocognitive impairment measured by TMT	Trail Making Test (TMT) is a test of executive functioning, visual search speed, scanning, speed of processing and mental flexibility. The total score is the time in seconds spent to complete each part.	6 months after admission at the intensive care unit
Secondary	Neurocognitive impairment by the short IQCODE	The short IQCODE is a 16 question long questionnaire that assesses cognitive impairment in elderly patients. An informant is required to rate a patient's cognitive changes over a 10 year time period. Each question is scored from 1 (much improved over time) to 5 (much worse).	6 months after admission at the intensive care unit