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临床试验/NCT05299346
NCT05299346已完成不适用

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

Sahlgrenska University Hospital1 个研究点 分布在 1 个国家目标入组 793 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
793
试验地点
1
主要终点
Lung Function, end tidal Co2 in kPa

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Under 18 years of age at time of inclusion
  • Not a Swedish resident
  • Unwillingness to participate

结局指标

主要结局

Lung Function, end tidal Co2 in kPa

时间窗: One year

Respiratory function following Covid19, end tidal carbon dioxide in kPa,

Cardiac biomarkers Troponin in ng/L

时间窗: One year

Cardiac function Blood sampling

Cardiac ultrasound

时间窗: One year

Cardiac ultrasound including ejection fractions (EF%)

Covid 19 antibodies

时间窗: One year

Antibodies IgG against Covid 19 lab test

Lung Function, complete arterial and venous blood gas in kPa

时间窗: One year

Respiratory function with arterial and venous blood gas pO2 and pCO2 in kPa

Lung Function oxygen saturation

时间窗: One year

Respiratory function following Covid19, saturation in SaO2%

Lung parenchym status

时间窗: One year

Ct scan of the lungs, assessed by radiology specialist, assessed for fibrosis, bronchiectasia and residual ground glass abnormalities

Cognitive function MMSE

时间窗: One year

Standardized cognitive tests

Cognitive function Montreal Cognitive Assessment

时间窗: One year

Standardized cognitive tests

Cognitive function CDR

时间窗: One year

Standardized cognitive tests,

Lung Function spirometry

时间窗: One year

Respiratory function with spirometry in Volumes in ml related to BMI

ECG

时间窗: One year

5 lead ECG for the detection av arrythmia

Cardiac biomarkers NTproBNPin ng/L

时间窗: One year

Cardiac function Blood sampling

Cognitive function biochemical markers

时间窗: One year

blood sampling with NFL, NSE, s-100B, fosfor-tau and APOE

Physical function

时间窗: One year

Standardized aggregate test of physical function, including seat raise test and grip strength measurement with validated instruments

Coagulation Status

时间窗: One year

Blood sampling Fibrinogen, D-Dimer, Antithrombin III and platelets, Aggregate variable to determine overall coagulation status

次要结局

  • Frailty(One year)
  • Return to own home(one year)
  • Return to work(One year)
  • New need for nursing assistance at home?(one year)
  • Mental fatigue(One Year)

研究者

发起方
Sahlgrenska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bengt Nellgård

MD PhD Associate Professor

Sahlgrenska University Hospital

研究点 (1)

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