Clinical trial NCT04974775: Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls
Official title: Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Cardiac Arrest
Sepsis
Influenza
Covid19
Trauma
Keywords: Biobank
Critical Illness
Cardiac Arrest
Sepsis
Influenza
Covid-19
Trauma
Prognosis
Neurology
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Region Skane
name: Lund University
First posted: 2021-07-23
Enrollment: 8500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All critically ill patients admitted to the participating ICUs in Region Skane (2015-2018), and a healthy control group.

Starting in May 2020, critically ill Covid-19 patients admitted to an ICU in the Skane Region are prospectively included.

Brief summary: Blood samples are collected and stored in a biobank for later analysis of circulating substances in peripheral blood and genetic variations in patients with severe critical illness and risk of death. The aim is to analyze stored samples in order to identify substances that can help predict the outcome of critically ill patients, but also to optimize treatment and possibly prevent serious illness and death in the future.

Detailed description: SWECRIT is a regional, multicenter study with prospective collection of blood samples and background information from critically ill patients, admitted to an Intensive Care Unit (ICU) in Region Skåne, Sweden. Patients were originally categorized into four study cohorts a) cardiac arrest, b) sepsis, c) influenza, and d) trauma. In April of 2020, a fifth study cohort, covid19, was added to the original ones. In addition, a control group of healthy controls has been enrolled.

Diagnoses, disease course, treatment results and survival are prospectively collected from all critically ill patients in the Patient Administrative System for Intensive Care Units (PASIVA). PASIVA is the portal by which collected laboratory and physiological data are entered into the Swedish Intensive Care Register (SIR). Further data are collected retrospectively from other health-related registers, such as the Swedish Population Register, the International Cardiac Arrest Registry (INTCAR), The Swedish CPR Registry, the Swedish Trauma Registry (SweTrau), and the Regional quality register Covid-IR (covid19 disease).

Specifically for the covid19-cohort, detailed face-to-face follow-up will be performed of all survivors at 3 \& 12 months and a telephone interview after 3 years. Questionnaires (see below) will be sent to patients prior to the follow-up. Questions about well-being in general, quality-of-life, sleeping disorders, psychological and psychiatric problems will be addressed.

Collected blood samples in the ICU are processed by clinical chemistry at each participating hospital and frozen specimens of whole blood, serum, and plasma (200 ul aliquots) are sent to the biobank BD-47 in Region Skane for long-term storage (maximum 20 years).

The circulating substances and genetic markers, i.e. biomarkers that will be analyzed are: proteins (markers of inflammation, stress, infection, neurologic injury, myocardial injury and endothelial function) and other circulating substances in the blood (metabolomics), genes (DNA) from the entire genome, epigenetic changes (eg methylation status of DNA), gene fragments (eg secretory DNA), various forms of RNA such as micro-RNA \& longcoding RNA.

Research questions for future analyzes of collected samples are specified but subject to change, depending on progress and development in the specific research field of each study cohort.

1. Identification and use of biomarkers for assessment of severity of disease and trajectory over time in the ICU will be the main area of research.
2. Assessment of neurological prognosis and outcomes will be a common denominator in several studies.
3. Descriptive statistics and regression analyses will be performed in order to identify independent variables (biomarkers) of importance for prognosis and outcomes.

Inquiries to access the sample collection for research purpose can be sent to the central contacts listed below.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients admitted to the ICU
* 18 years or older
* covid19-verified (covid19-cohort)

Exclusion Criteria:

* The patient or next of kin decline participation

Primary outcomes:
measure: Mortality (all)
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients with good neurological outcome 1 (all)
timeFrame: 3-6 months
measure: Proportion of patients with good neurological outcome 2 (all)
timeFrame: 3-6 months
measure: Neurological outcome 3 (covid19)
timeFrame: 3-6 months
Other outcomes:
measure: Severity of the Acute Respiratory Distress Syndrome (ARDS) (covid19)
timeFrame: On ICU admission
measure: Proportion of patients with pathological Pulmonary Function Testing (PFT)
timeFrame: 3 and 12 months
measure: Subjective respiratory function (covid19)
timeFrame: 3, 12 and 36 months
measure: Physical problems (covid19)
timeFrame: 3, 12 and 36 months
measure: Proportion of patients with significant Fatigue (covid19)
timeFrame: 3, 12 and 36 months
measure: Hospital Anxiety and Depression Scale (covid19)
timeFrame: 3, 12 and 36 months
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Kristianstad
country: Sweden
facility: Kristianstad Central Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Skane University Hospital
name: Hans Friberg, MD, PhD
role: STUDY_CHAIR
References:
citation: Lengquist M, Lundberg OHM, Spangfors M, Annborn M, Levin H, Friberg H, Frigyesi A. Sepsis is underreported in Swedish intensive care units: A retrospective observational multicentre study. Acta Anaesthesiol Scand. 2020 Sep;64(8):1167-1176. doi: 10.1111/aas.13647. Epub 2020 Jun 18.
citation: Lundberg OHM, Lengquist M, Spangfors M, Annborn M, Bergmann D, Schulte J, Levin H, Melander O, Frigyesi A, Friberg H. Circulating bioactive adrenomedullin as a marker of sepsis, septic shock and critical illness. Crit Care. 2020 Nov 4;24(1):636. doi: 10.1186/s13054-020-03351-1.
citation: Thorgeirsdottir B, Levin H, Spangfors M, Annborn M, Cronberg T, Nielsen N, Lybeck A, Friberg H, Frigyesi A. Plasma proenkephalin A 119-159 and dipeptidyl peptidase 3 on admission after cardiac arrest help predict long-term neurological outcome. Resuscitation. 2021 Jun;163:108-115. doi: 10.1016/j.resuscitation.2021.04.021. Epub 2021 Apr 27.
citation: Johnsson J, Bjornsson O, Andersson P, Jakobsson A, Cronberg T, Lilja G, Friberg H, Hassager C, Kjaergard J, Wise M, Nielsen N, Frigyesi A. Artificial neural networks improve early outcome prediction and risk classification in out-of-hospital cardiac arrest patients admitted to intensive care. Crit Care. 2020 Jul 30;24(1):474. doi: 10.1186/s13054-020-03103-1.