Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06042790 |
| Other study ID # |
SwedishICR |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
October 8, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Swedish Intensive Care Registry |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Covid-19 is a disease where both clinical experience and thus knowledge about the long-term
effects of the disease are currently sparse. However, current follow-up results indicate a
more pronounced cognitive and respiratory impairment than previously seen in a normal ICU
population. As we know that the prevalence of impairments in neurocognitive and Health
Related Quality of Life (HRQoL) is increased in a majority of ICU patients, it would be of
benefit to gain knowledge about the impact on the recovery trajectory for patients treated
for Covid-19, and to increase the understanding of which factors that affect the HRQoL and
recovery and in what way these differs between patients treated in ICU for Covid-19 and other
causes respectively. This can contribute to better structures for follow-up and possibility
to individualisation that better address which patients are in risk for decreased HRQoL and
where benefit for the patient, health care and social economic can be achieved.
Description:
Introduction During 2020, an infection disease caused by the new coronavirus Sars-Cov2,
Covid-19 were globally spread in the world. Covid-19 caused extensive consequences to the
society, economy, and health care. In some of the patients the symptoms progressed to a
life-threatening respiratory failure whit a need for intensive care. The intensive care was
complicated then the progress of the disease was not followed the usual care for patients
with difficult respiratory disease. Many of the patients with Covid-19 required deeper
sedation with high-doses of anaesthesia and muscle relaxants and long time in ventilator.
This is not in line with the current evidence regarding ventilator treatment and sedation in
intensive care and for considered to constitute risk-factors for intensive care related
residuals symptoms and worsened long-time results as well as increased mortality. In
addition, the hospitals had restrictions regarding visitors and the relatives were not
allowed to visit patients at the Intensive Care Unit (ICU). The presence of relatives is
estimated in intensive care patients as one of the most important factors contributing to
their recovery.
Today we know that intensive care patients had a risk to get physical, mental, and cognitive
problems long time after hospital discharge. Other common residual problems as anxiety,
depression, and post-traumatic stress (PTSD) can also occurred after intensive care. However,
there are an increased risk that ICU patients with Covid-19 experience physical, and mental
problems and decreased health related quality of life (HRQoL), then the environment at ICU
during the Covid-19 pandemic, could predispose for cognitive failure and PTSD. The knowledge
about this is limited. Today, data indicate that fatigue and dyspnoea are common residual
symptoms which affect the HRQoL in multiple dimensions long time after hospital discharge.
Since 2005 the Swedish Intensive Care Registry (SIR) recommend to follow-up former ICU
patients HRQoL (RAND-36), BMI, ADL and working capacity. We have now a unique chance to
describe how patients taken care for Covid-19 in ICU experience their HRQoL with physical,
mental, and cognitive problems compared to patients who were cared for in ICU for reasons
other than Covid-19, and if they changed over time in relation to changed treatment
conditions. It is important to map which risk factors that affect patients HRQoL.
International studies show that factors important to HRQoL after intensive care are: age,
comorbidity, the severity of the illness, length of stay, diagnose, PTSD, and symptoms of
depression. It is likely that other factors also play a decisive role, such as socioeconomics
factors. The purpose of this study is to deepen the analyse and identify other factors that
are important for the patients HRQoL.
Aim The aim is to increase the knowledge about adult patient's whit Covid-19 taken care of at
ICUs in Sweden estimate their HRQoL during the first year after ICU discharge and compare
their HRQoL with patients taken care at ICU for other reasons than Covid-19 and which
risk-factors affect the HRQoL and if there are any discrepancy between the groups.
Research-questions Are there differences in self-estimated HRQoL between patients care for
Covid-19 and patients cared for other reasons at ICU, at 3, 6 and 12 months after ICU
discharge? Method Design: National quality register study. Participants/sample size: All
adult patients ≥18 year who have been treated at ICUs in Sweden and have a registered
follow-up in SIR. (Covid-19 and non-Covid-19).
Data Collection:
Anonymous data collected from the Swedish intensive quality register (SIR), the national
patient register in the National board of health and welfare, and the Statistics Sweden (SBC)
LISA register for patients cared for in ICU and how have a registered RAND-36 in SIR. The
Covid-19 group include patients cared in ICU between 01-03-2020 and as long as the pandemic
is ongoing. The non-Covid-19 group includes patients how have been cared in ICU 01-01-2017
until 31-12-2019, before the outbreak of the pandemic to get the best comparing data. The
reasons to include data from SIR are 1) to reduce the effort for the patients, to fill in
more questionnaires and 2) that the time before outbreak of Covid-19 is more valid to compare
with then the intensive care during the Covid-19 pandemic have to deviate from their usual
regimen regarding care and treatment as well as the selection of patients and a comparison
during the Covid period therefore has a risk of bias Data analysis Data compiled on
group-level and to be used to compare between the groups. Quantitative methods are used to
describe tendances in the group and analysis of differences between the groups. Data
regarding demography and comorbidity analysis descriptively at group level.
Association is investigated with correlation and regression analysis, t-test or
corresponding.
Comparison between the groups is done with t-test parametric data and Mann-Whitney
non-parametric variables. Identifying of factors influencing the outcome of RAND-36 (HRQoL)
is done with univariate regression analysis. Values with significant outcomes are further
analysed with multivariate regression analysis for identification of independent risk factors
versus outcomes in RAND-36 (HRQoL). The results of variate analysis reports as OR.
