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

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.

Study Overview

• Status: Completed
• Conditions: Delirium; COVID-19 Pandemic; Intensive Care Unit Syndrome
• Intervention / Treatment: Other: Follow up

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

• Study Type: Observational
• Enrollment (Actual): 793

Contacts and Locations

Study Locations

• Sweden
  • Vastra Gotaland
    • Molndal, Vastra Gotaland, Sweden, 431 80
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post ICU covid survivors; Patients having survived and discharged from ICU care as a result of Covid 19	Other: Follow up; Comprehensive follow up in dedicated follow up unit

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: March 27, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive function; covid19; Lung function; Heart function
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: PICU COVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to small sample size, anonymity will be difficult if data is shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No