Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04881266 |
| Other study ID # |
2021-00209 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 7, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
May 2021 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
