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

Active, not recruiting

• Conditions: COVID-19 Pandemic; Delirium; Intensive Care Unit Syndrome
• Interventions: Other: Follow up

• Registration Number: NCT05299346
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

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 Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2022-03-27
• Study First Posted: 2022-03-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 793

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post ICU covid survivors	Follow up	Patients having survived and discharged from ICU care as a result of Covid 19

Primary Outcome Measures

Name	Time	Method
Lung Function oxygen saturation	One year	Respiratory function following Covid19, saturation in SaO2%
Lung parenchym status	One year	Ct scan of the lungs, assessed by radiology specialist, assessed for fibrosis, bronchiectasia and residual ground glass abnormalities
Cognitive function MMSE	One year	Standardized cognitive tests
Cognitive function Montreal Cognitive Assessment	One year	Standardized cognitive tests
Lung Function, end tidal Co2 in kPa	One year	Respiratory function following Covid19, end tidal carbon dioxide in kPa,
Cardiac biomarkers Troponin in ng/L	One year	Cardiac function Blood sampling
Cardiac ultrasound	One year	Cardiac ultrasound including ejection fractions (EF%)
Covid 19 antibodies	One year	Antibodies IgG against Covid 19 lab test
Lung Function, complete arterial and venous blood gas in kPa	One year	Respiratory function with arterial and venous blood gas pO2 and pCO2 in kPa
Cognitive function CDR	One year	Standardized cognitive tests,
Lung Function spirometry	One year	Respiratory function with spirometry in Volumes in ml related to BMI
ECG	One year	5 lead ECG for the detection av arrythmia
Cardiac biomarkers NTproBNPin ng/L	One year	Cardiac function Blood sampling
Cognitive function biochemical markers	One year	blood sampling with NFL, NSE, s-100B, fosfor-tau and APOE
Physical function	One year	Standardized aggregate test of physical function, including seat raise test and grip strength measurement with validated instruments
Coagulation Status	One year	Blood sampling Fibrinogen, D-Dimer, Antithrombin III and platelets, Aggregate variable to determine overall coagulation status

Secondary Outcome Measures

Name	Time	Method
Return to own home	one year	Are the subjects living in their original housing or equivalent?
Frailty	One year	assessed accordingly to Clinical frailty scale
Return to work	One year	Are the subjects working or at the disposal of the labour market
New need for nursing assistance at home?	one year	Are the subjects in need of in home nursing care
Mental fatigue	One Year	self-assessment questionnaire Mental fatigue scale

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Molndal, Vastra Gotaland, Sweden