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Completed

NCT Number: NCT05299346

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow up

Other

Comprehensive follow up in dedicated follow up unit

Primary outcomes

  1. Lung Function oxygen saturation

    Time frame: One year

    Respiratory function following Covid19, saturation in SaO2%

  2. Lung Function, end tidal Co2 in kPa

    Time frame: One year

    Respiratory function following Covid19, end tidal carbon dioxide in kPa,

  3. Lung Function, complete arterial and venous blood gas in kPa

    Time frame: One year

    Respiratory function with arterial and venous blood gas pO2 and pCO2 in kPa

  4. Lung Function spirometry

    Time frame: One year

    Respiratory function with spirometry in Volumes in ml related to BMI

  5. Lung parenchym status

    Time frame: One year

    Ct scan of the lungs, assessed by radiology specialist, assessed for fibrosis, bronchiectasia and residual ground glass abnormalities

  6. ECG

    Time frame: One year

    5 lead ECG for the detection av arrythmia

  7. Cardiac ultrasound

    Time frame: One year

    Cardiac ultrasound including ejection fractions (EF%)

  8. Cardiac biomarkers Troponin in ng/L

    Time frame: One year

    Cardiac function Blood sampling

  9. Cardiac biomarkers NTproBNPin ng/L

    Time frame: One year

    Cardiac function Blood sampling

  10. Cognitive function MMSE

    Time frame: One year

    Standardized cognitive tests

  11. Cognitive function CDR

    Time frame: One year

    Standardized cognitive tests,

  12. Cognitive function Montreal Cognitive Assessment

    Time frame: One year

    Standardized cognitive tests

  13. Cognitive function biochemical markers

    Time frame: One year

    blood sampling with NFL, NSE, s-100B, fosfor-tau and APOE

  14. Physical function

    Time frame: One year

    Standardized aggregate test of physical function, including seat raise test and grip strength measurement with validated instruments

  15. Coagulation Status

    Time frame: One year

    Blood sampling Fibrinogen, D-Dimer, Antithrombin III and platelets, Aggregate variable to determine overall coagulation status

  16. Covid 19 antibodies

    Time frame: One year

    Antibodies IgG against Covid 19 lab test

Secondary outcomes

  1. Return to work

    Time frame: One year

    Are the subjects working or at the disposal of the labour market

  2. Return to own home

    Time frame: one year

    Are the subjects living in their original housing or equivalent?

  3. New need for nursing assistance at home?

    Time frame: one year

    Are the subjects in need of in home nursing care

  4. Frailty

    Time frame: One year

    assessed accordingly to Clinical frailty scale

  5. Mental fatigue

    Time frame: One Year

    self-assessment questionnaire Mental fatigue scale

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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