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

NCT05299346 | Completed

• 1 other identifier: PICU COVID19
• Study Type: observational
• Target: 793
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic; Intensive Care Unit Syndrome; Delirium

Keywords

covid19; Heart function; Lung function; Cognitive function

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (5)

• Return to work

  One year

• Return to own home

  one year

• New need for nursing assistance at home?

  one year

• Frailty

  One year

• Mental fatigue

  One Year

Study Arms (1)

Post ICU covid survivors

Patients having survived and discharged from ICU care as a result of Covid 19

Other: Follow up

Interventions

Follow up OTHER

Comprehensive follow up in dedicated follow up unit

Post ICU covid survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients treated at the Intensive Care Unit at Mölndals hospital from 2020 to 2022 for Covid19
• More than 3 months passed since ICU discharge
• Swedish resident with Swedish unique personal identification number.
• Informed consent

You may not qualify if:

• Not a Swedish resident
• Unwillingness to participate

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, 431 80, Sweden

Location

Related Publications (11)

• 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.

  PMID: 32071063 BACKGROUND

• 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.

  PMID: 32236644 BACKGROUND

• 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.

  PMID: 28619367 BACKGROUND

• 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.

  PMID: 32273593 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

• 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.

  PMID: 32265220 BACKGROUND

• 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.

  PMID: 32282949 BACKGROUND

• 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.

  PMID: 25015102 BACKGROUND

• 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.

  PMID: 26134971 BACKGROUND

• 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.

  PMID: 31361336 BACKGROUND

• 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.

  PMID: 32341111 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

COVID-19; Delirium

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Associate Professor

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: March 29, 2022
• Study Start: October 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)