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Clinical Trials/NCT04593069
NCT04593069
Completed
Not Applicable

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

Ziekenhuis Oost-Limburg1 site in 1 country70 target enrollmentOctober 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Ziekenhuis Oost-Limburg
Enrollment
70
Locations
1
Primary Endpoint
Neurocognitive impairment measured by RBANS
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 7, 2020
End Date
January 13, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ziekenhuis Oost-Limburg
Responsible Party
Principal Investigator
Principal Investigator

Dieter Mesotten

MD

Ziekenhuis Oost-Limburg

Eligibility Criteria

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

Outcomes

Primary Outcomes

Neurocognitive impairment measured by RBANS

Time Frame: 6 months after admission at the intensive care unit

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

Secondary Outcomes

  • 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 Sites (1)

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