Post-ICU Follow-up Study in Covid-19 Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Post-ICU Covid19 Follow-up With Regards to Lung, Heart, Kidney and Cognitive Function

Conditions
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COVID-19 Pandemic, Intensive Care Unit Syndrome, Delirium

Intervention / Treatment
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* Other: Follow up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post ICU covid survivors<br>Patients having survived and discharged from ICU care as a result of Covid 19 | Other: Follow up<br>* Comprehensive follow up in dedicated follow up unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Function oxygen saturation | Respiratory function following Covid19, saturation in SaO2% | One year | 
| Lung Function, end tidal Co2 in kPa | Respiratory function following Covid19, end tidal carbon dioxide in kPa, | One year | 
| Lung Function, complete arterial and venous blood gas in kPa | Respiratory function with arterial and venous blood gas pO2 and pCO2 in kPa | One year | 
| Lung Function spirometry | Respiratory function with spirometry in Volumes in ml related to BMI | One year | 
| Lung parenchym status | Ct scan of the lungs, assessed by radiology specialist, assessed for fibrosis, bronchiectasia and residual ground glass abnormalities | One year | 
| ECG | 5 lead ECG for the detection av arrythmia | One year | 
| Cardiac ultrasound | Cardiac ultrasound including ejection fractions (EF%) | One year | 
| Cardiac biomarkers Troponin in ng/L | Cardiac function Blood sampling | One year | 
| Cardiac biomarkers NTproBNPin ng/L | Cardiac function Blood sampling | One year | 
| Cognitive function MMSE | Standardized cognitive tests | One year | 
| Cognitive function CDR | Standardized cognitive tests, | One year | 
| Cognitive function Montreal Cognitive Assessment | Standardized cognitive tests | One year | 
| Cognitive function biochemical markers | blood sampling with NFL, NSE, s-100B, fosfor-tau and APOE | One year | 
| Physical function | Standardized aggregate test of physical function, including seat raise test and grip strength measurement with validated instruments | One year | 
| Coagulation Status | Blood sampling Fibrinogen, D-Dimer, Antithrombin III and platelets, Aggregate variable to determine overall coagulation status | One year | 
| Covid 19 antibodies | Antibodies IgG against Covid 19 lab test | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Are the subjects working or at the disposal of the labour market | One year | 
| Return to own home | Are the subjects living in their original housing or equivalent? | one year | 
| New need for nursing assistance at home? | Are the subjects in need of in home nursing care | one year | 
| Frailty | assessed accordingly to Clinical frailty scale | One year | 
| Mental fatigue | self-assessment questionnaire Mental fatigue scale | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19, Heart function, Lung function, Cognitive function