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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05299346
Other study ID # PICU COVID19
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date June 1, 2023

Study information

Verified date October 2022
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 793
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Follow up
Comprehensive follow up in dedicated follow up unit

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Molndal Vastra Gotaland

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: 2001028. doi: 10.1183/13993003.01028-2020. Print 2020 May. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: BMJ. 2020 Jun 3;369:m2204. Update in: BMJ. 2021 Feb 3;372:n236. — View Citation

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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Lung Function oxygen saturation Respiratory function following Covid19, saturation in SaO2% One year
Primary Lung Function, end tidal Co2 in kPa Respiratory function following Covid19, end tidal carbon dioxide in kPa, One year
Primary 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
Primary Lung Function spirometry Respiratory function with spirometry in Volumes in ml related to BMI One year
Primary Lung parenchym status Ct scan of the lungs, assessed by radiology specialist, assessed for fibrosis, bronchiectasia and residual ground glass abnormalities One year
Primary ECG 5 lead ECG for the detection av arrythmia One year
Primary Cardiac ultrasound Cardiac ultrasound including ejection fractions (EF%) One year
Primary Cardiac biomarkers Troponin in ng/L Cardiac function Blood sampling One year
Primary Cardiac biomarkers NTproBNPin ng/L Cardiac function Blood sampling One year
Primary Cognitive function MMSE Standardized cognitive tests One year
Primary Cognitive function CDR Standardized cognitive tests, One year
Primary Cognitive function Montreal Cognitive Assessment Standardized cognitive tests One year
Primary Cognitive function biochemical markers blood sampling with NFL, NSE, s-100B, fosfor-tau and APOE One year
Primary Physical function Standardized aggregate test of physical function, including seat raise test and grip strength measurement with validated instruments One year
Primary Coagulation Status Blood sampling Fibrinogen, D-Dimer, Antithrombin III and platelets, Aggregate variable to determine overall coagulation status One year
Primary Covid 19 antibodies Antibodies IgG against Covid 19 lab test One year
Secondary Return to work Are the subjects working or at the disposal of the labour market One year
Secondary Return to own home Are the subjects living in their original housing or equivalent? one year
Secondary New need for nursing assistance at home? Are the subjects in need of in home nursing care one year
Secondary Frailty assessed accordingly to Clinical frailty scale One year
Secondary Mental fatigue self-assessment questionnaire Mental fatigue scale One Year
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