Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls

Covid19 Clinical Trial

— SWECRIT  

Official title:

Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04974775
• Other study ID #: SWECRIT
• Status: Active, not recruiting
• Start date: June 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• COVID-19
• Covid19
• Critical Illness
• Heart Arrest
• Influenza
• Sepsis
• Trauma

Intervention

Diagnostic Test:
• Blood collection
Sampling on admission to ICU (all patients)
• Blood collection, serial sampling
Additional sampling to admission samples in the Cardiac Arrest group after 12 and 48 hours the Covid-19 group on day 2 and 7 while in the ICU the Covid-19 group after 3 and 12 months.

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Kristianstad Central Hospital	Kristianstad
Sweden	Skane University Hospital	Lund
Sweden	Skane University Hospital	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Skane University Hospital	Lund University, Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. Erratum In: Acta Anaesthesiol Scand. 2021 Jan;65(1):140. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of the Acute Respiratory Distress Syndrome (ARDS) (covid19)	Patients fulfilling the ARDS criteria are categorized into mild, moderate or severe, depending on the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (FiO2). Mild: < 300, Moderate: < 200, Severe: < 100.	On ICU admission
Other	Proportion of patients with pathological Pulmonary Function Testing (PFT)	A composite of Total Lung Capacity (TLC) & Diffusion capacity (DLCO) compared to a population norm. Less than 80 % of the (age-adjusted) population norm is considered pathological.	3 and 12 months
Other	Subjective respiratory function (covid19)	Saint George's Respiratory Questionnaire 0-100 (SGRQ 0-100), lower values representing better function and higher values representing worse function. 8.41 (SD 11.33) is considered a normative value (Spanish population).	3, 12 and 36 months
Other	Physical problems (covid19)	Short form Health Survey, version 2, physical function 10 (SF-36 v.2 PF-10), 10 items, higher score for each item represents better function. Scores are transformed to T-scores based on norm-based values. A T-score of 50 indicates the norm mean for each item. At a group level scores <47 and individual scores <45 indicate low physical function.	3, 12 and 36 months
Other	Proportion of patients with significant Fatigue (covid19)	Modified fatigue impact scale 0-84 (MFIS 0-84), higher values representing more fatigue and lower numbers representing less fatigue. A value >38 discriminates significant fatigue.	3, 12 and 36 months
Other	Hospital Anxiety and Depression Scale (covid19)	Anxiety and depression. Two sub-scales with 7 items in each, higher values represent more anxiety and depression, >8 points in each sub-scale indicates significant symptoms of anxiety and depression.	3, 12 and 36 months
Primary	Mortality (all)	Primary outcome when functional outcome cannot be assessed.	6 months
Secondary	Proportion of patients with good neurological outcome 1 (all)	Neurological outcome assessed using Cerebral Performance Category 1-5 (CPC 1-5), CPC 1 representing the best and CPC 5 the worst outcome. Good outcome is defined as CPC 1-2, poor outcome as CPC 3-5.	3-6 months
Secondary	Proportion of patients with good neurological outcome 2 (all)	Modified Rankin Score 0-6 (mRS 0-6), mRS 0 representing the best and mRS 6 representing the worst outcome. Good outcome is defined as mRS 0-3, poor outcome as mRS 3-6.	3-6 months
Secondary	Neurological outcome 3 (covid19)	Glasgow Outcome Scale Extended 1-8 (GOSE 1-8), GOSE 1 representing the worst outcome and GOSE 8 the best outcome.	3-6 months