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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05299346
• Other study ID #: PICU COVID19
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Delirium
• Intensive Care Unit Syndrome

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 all — Click 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