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COVID-19 PandemicNCT05299346

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

An observational study of COVID-19 Pandemic and Intensive Care Unit Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Follow up
How many people
793 participants
Where
1 siteSweden
Study dates
1 Oct 2020to 1 Sep 2023
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients that have been treated for Covid 19 at the ICU at Mölndal are eligible for participation

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Mölndal, Västra Götaland County, 431 80

Other trials in Sweden

About this study

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

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.

Read the 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
Being tested
Follow up
Keywords
covid19, Heart function, Lung function, Cognitive function
Medical subject headings
COVID-19, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follow upOther

    Comprehensive follow up in dedicated follow up unit

Study groups in NCT05299346
Study groupRoleWhat they receive
Post ICU covid survivorsPatients having survived and discharged from ICU care as a result of Covid 19
Receives: Other: Follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lung Function oxygen saturation

    Respiratory function following Covid19, saturation in SaO2%

    Measured: One year

  2. Lung Function, end tidal Co2 in kPa

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

    Measured: One year

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

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

    Measured: One year

  4. Lung Function spirometry

    Respiratory function with spirometry in Volumes in ml related to BMI

    Measured: One year

  5. Lung parenchym status

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

    Measured: One year

  6. ECG

    5 lead ECG for the detection av arrythmia

    Measured: One year

  7. Cardiac ultrasound

    Cardiac ultrasound including ejection fractions (EF%)

    Measured: One year

  8. Cardiac biomarkers Troponin in ng/L

    Cardiac function Blood sampling

    Measured: One year

  9. Cardiac biomarkers NTproBNPin ng/L

    Cardiac function Blood sampling

    Measured: One year

  10. Cognitive function MMSE

    Standardized cognitive tests

    Measured: One year

  11. Cognitive function CDR

    Standardized cognitive tests,

    Measured: One year

  12. Cognitive function Montreal Cognitive Assessment

    Standardized cognitive tests

    Measured: One year

  13. Cognitive function biochemical markers

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

    Measured: One year

  14. Physical function

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

    Measured: One year

  15. Coagulation Status

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

    Measured: One year

  16. Covid 19 antibodies

    Antibodies IgG against Covid 19 lab test

    Measured: One year

Secondary outcomes (5)

  1. Return to work

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

    Measured: One year

  2. Return to own home

    Are the subjects living in their original housing or equivalent?

    Measured: one year

  3. New need for nursing assistance at home?

    Are the subjects in need of in home nursing care

    Measured: one year

  4. Frailty

    assessed accordingly to Clinical frailty scale

    Measured: One year

  5. Mental fatigue

    self-assessment questionnaire Mental fatigue scale

    Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2022
  2. Study start1 Oct 2020
  3. Primary completion1 Jun 2023
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
793 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05299346
Sponsor's protocol ID
PICU COVID19
Status last verified
May 2025
First submitted
21 Oct 2021
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to small sample size, anonymity will be difficult if data is shared

Publications

  • Mahase E. Coronavirus covid-19 has killed more people than SARS and MERS combined, despite lower case fatality rate. BMJ. 2020 Feb 18;368:m641. doi: 10.1136/bmj.m641. No abstract available.

    PubMed 32071063

  • Pan XW, Xu D, Zhang H, Zhou W, Wang LH, Cui XG. Identification of a potential mechanism of acute kidney injury during the COVID-19 outbreak: a study based on single-cell transcriptome analysis. Intensive Care Med. 2020 Jun;46(6):1114-1116. doi: 10.1007/s00134-020-06026-1. Epub 2020 Mar 31. No abstract available.

    PubMed 32236644

  • Li XC, Zhang J, Zhuo JL. The vasoprotective axes of the renin-angiotensin system: Physiological relevance and therapeutic implications in cardiovascular, hypertensive and kidney diseases. Pharmacol Res. 2017 Nov;125(Pt A):21-38. doi: 10.1016/j.phrs.2017.06.005. Epub 2017 Jun 12.

    PubMed 28619367

  • Ronco C, Reis T. Kidney involvement in COVID-19 and rationale for extracorporeal therapies. Nat Rev Nephrol. 2020 Jun;16(6):308-310. doi: 10.1038/s41581-020-0284-7.

    PubMed 32273593

  • Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

    PubMed 32171076

  • Wynants L, Van Calster B, Collins GS, Riley RD, Heinze G, Schuit E, Bonten MMJ, Dahly DL, Damen JAA, Debray TPA, de Jong VMT, De Vos M, Dhiman P, Haller MC, Harhay MO, Henckaerts L, Heus P, Kammer M, Kreuzberger N, Lohmann A, Luijken K, Ma J, Martin GP, McLernon DJ, Andaur Navarro CL, Reitsma JB, Sergeant JC, Shi C, Skoetz N, Smits LJM, Snell KIE, Sperrin M, Spijker R, Steyerberg EW, Takada T, Tzoulaki I, van Kuijk SMJ, van Bussel B, van der Horst ICC, van Royen FS, Verbakel JY, Wallisch C, Wilkinson J, Wolff R, Hooft L, Moons KGM, van Smeden M. Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal. BMJ. 2020 Apr 7;369:m1328. doi: 10.1136/bmj.m1328.

    PubMed 32265220

  • Terpos E, Ntanasis-Stathopoulos I, Elalamy I, Kastritis E, Sergentanis TN, Politou M, Psaltopoulou T, Gerotziafas G, Dimopoulos MA. Hematological findings and complications of COVID-19. Am J Hematol. 2020 Jul;95(7):834-847. doi: 10.1002/ajh.25829. Epub 2020 May 23.

    PubMed 32282949

  • Orde SR, Pulido JN, Masaki M, Gillespie S, Spoon JN, Kane GC, Oh JK. Outcome prediction in sepsis: speckle tracking echocardiography based assessment of myocardial function. Crit Care. 2014 Jul 11;18(4):R149. doi: 10.1186/cc13987.

    PubMed 25015102

  • Dalla K, Hallman C, Bech-Hanssen O, Haney M, Ricksten SE. Strain echocardiography identifies impaired longitudinal systolic function in patients with septic shock and preserved ejection fraction. Cardiovasc Ultrasound. 2015 Jul 2;13:30. doi: 10.1186/s12947-015-0025-4.

    PubMed 26134971

  • Dalla K, Bech-Hanssen O, Ricksten SE. Impact of norepinephrine on right ventricular afterload and function in septic shock-a strain echocardiography study. Acta Anaesthesiol Scand. 2019 Nov;63(10):1337-1345. doi: 10.1111/aas.13454. Epub 2019 Aug 19.

    PubMed 31361336

  • Rello J, Storti E, Belliato M, Serrano R. Clinical phenotypes of SARS-CoV-2: implications for clinicians and researchers. Eur Respir J. 2020 May 21;55(5):2001028. doi: 10.1183/13993003.01028-2020. Print 2020 May.

    PubMed 32341111

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 Pandemic and Intensive Care Unit Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung Function oxygen saturation (time frame: One year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05299346, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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