Clinical trial NCT05299346: Post-ICU Follow-up Study in Covid-19 Patients
Official title: Post-ICU Covid19 Follow-up With Regards to Lung, Heart, Kidney and Cognitive Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Intensive Care Unit Syndrome
Delirium
Keywords: covid19
Heart function
Lung function
Cognitive function
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that have been treated for Covid 19 at the ICU at Mölndal are eligible for participation

Brief summary: A follow up study of adult patients who have been treated in the ICU at Mölndal hospital due to Covid19 in the period of 2020 to 2022.

Detailed description: The spread of Covid19 in the population in Sweden from 2019 and onwards posed new and serious strain on our ICU capacity. The disease presented with initially influenza like symptoms and evolved into multiorgan failure. 5% of all patients with verified Covid 19 were in need of critical care and among them the in-hospital mortality rate was 20%.

Patients will be followed up with after a minimum of three months after discharge from the ICU with regards to organ function.

Examinations within the scope of the study are;

* Comprehensive heart investigation including ultrasound
* Arterial blood gas and lung function tests including computer tomography of the lungs.
* Cognitive function with validated questioners
* Standardized test of physical function
* A panel of blood samples to assess organ function

Eligibility criteria: Inclusion Criteria:

* Patients treated at the Intensive Care Unit at Mölndals hospital from 2020 to 2022 for Covid19
* More than 3 months passed since ICU discharge
* Over 18 years of age at time of inclusion
* Swedish resident with Swedish unique personal identification number.
* Informed consent

Exclusion Criteria:

* Under 18 years of age at time of inclusion
* Not a Swedish resident
* Unwillingness to participate

Primary outcomes:
measure: Lung Function oxygen saturation
timeFrame: One year
measure: Lung Function, end tidal Co2 in kPa
timeFrame: One year
measure: Lung Function, complete arterial and venous blood gas in kPa
timeFrame: One year
measure: Lung Function spirometry
timeFrame: One year
measure: Lung parenchym status
timeFrame: One year
measure: ECG
timeFrame: One year
measure: Cardiac ultrasound
timeFrame: One year
measure: Cardiac biomarkers Troponin in ng/L
timeFrame: One year
measure: Cardiac biomarkers NTproBNPin ng/L
timeFrame: One year
measure: Cognitive function MMSE
timeFrame: One year
measure: Cognitive function CDR
timeFrame: One year
measure: Cognitive function Montreal Cognitive Assessment
timeFrame: One year
measure: Cognitive function biochemical markers
timeFrame: One year
measure: Physical function
timeFrame: One year
measure: Coagulation Status
timeFrame: One year
measure: Covid 19 antibodies
timeFrame: One year
Secondary outcomes:
measure: Return to work
timeFrame: One year
measure: Return to own home
timeFrame: one year
measure: New need for nursing assistance at home?
timeFrame: one year
measure: Frailty
timeFrame: One year
measure: Mental fatigue
timeFrame: One Year
Other outcomes:
Locations:
city: Molndal
country: Sweden
facility: Sahlgrenska University Hospital
state: Vastra Gotaland
Study officials:
References:
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