Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors

NCT ID: NCT04881266

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2023-12-31

Brief Summary

The corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical ventilation requirement and in some cases even mandating use of extra-corporeal membrane oxygenation. Being a disease having affected up to 15'581'009 as of July 25th, with more than 635'173 deaths, the long-term repercussions are of foremost importance. Health care systems world-wide will be faced with the aftermath of COVID-19, and optimal understanding of the long-term progression of COVID-19 may aid in a better care of critically ill patients and enable specifically targeted rehabilitation programs to improve outcomes.

Primary objective of this study is to assess the repercussions of COVID-19 induced critical illness on long-term functional status, quality-of-life, neuropsychology and cognition

Detailed Description

Health-care systems are ever improving, organ-support is advancing towards un-thought of possibilities and critical care medicine is becoming a field of evidence. As a consequence critical illness is bridgeable in many cases and intensive care unit (ICU) and hospital outcomes account for excellent survival numbers. In contrast to intensivist believes for decades nevertheless, a patient's life is not restored to normality the moment ICU survival is achieved, the real crucible is but starting at that moment. Sequela after critical illness are manifold and impact the functional status, quality-of-life, neuropsychology as well as cognition of patients surviving, leading to higher incidences of co-morbidities and a shortened life-expectancy.

Specifically reflecting the complex interplay between acute respiratory distress syndrome and long-term outcomes, the last decade has seen a plethora of research elaborating on the long-term outcomes of patients having suffered acute respiratory distress syndrome. The serious functional limitations in patients post critical illness were mainly linked to muscle wasting and weakness, and only secondarily to lung function, neuropathies and other etiologies. Further, the impaired neuropsychological status, especially mediated by posttraumatic stress disorder, and cognitive status have a great impact on the reduced health status and quality-of-life. On the other hand nevertheless, pulmonary function was near normal after up-to 5 years of follow-up. Finally, the impact of acute respiratory distress syndrome (ARDS) and critical illness have on caregivers should not be forgotten, with high levels of depressive symptoms having been reported.

Similar sequela were also described during the severe acute respiratory syndrome (SARS) epidemic in 2003.

The corona virus disease 2019 (COVID-19), suddenly incepted in December 2019 in Wuhan, China, leading to one of the greatest health care emergencies of the last century. Acute exacerbation of the COVID-19 can develop to an ARDS in a significant proportion of hospitalized cases, leading to invasive mechanical ventilation requirement and in some cases even mandating use of extra-corporeal membrane oxygenation. The median length of stay and of mechanical ventilation support in COVID-19 have been shown to be elevated in comparison to other ARDS etiologies. Being a disease having affected up to 92 million people during the year 2020, with more than 1.9 Million deaths reported, the long-term repercussions are of foremost importance. Health care systems world-wide will be faced with the aftermath of COVID-19, and optimal understanding of the long-term progression of COVID-19 may aid in a better care of critically ill patients and enable specifically targeted rehabilitation programs to improve outcomes.

The overall objective of this study is therefore to evaluate the long-term outcomes of COVID-19 induced critical illness regarding functional status, quality-of-life, neuropsychology and cognition.

Conditions

Covid19; ARDS; Critical Illness; Neurocognitive Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Post Critical Illness due to COVID-19

No interventions assigned to this group

Caregivers of Post critically ill COVID-19 patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Previous admission to one of the participating centers for COVID-19 critical illness treatment
• Previously proven SARS-CoV-2 infection
• Critical COVID-19 defined as respiratory failure and/ or shock and/ or multiorgan dysfunction or failure
• Signed Study Informed Consent

Exclusion Criteria

• Age <18 years
• Rejection of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reto A Schuepbach, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Intensive Care Medicine, University Hospital Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2021-00209

Identifier Type: -

Identifier Source: org_study_id