Blood collection
Diagnostic TestSampling on admission to ICU (all patients)
NCT Number: NCT04974775
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Helsingborg Hospital, Helsingborg, Sweden
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.
Inquiries to access the sample collection for research purpose can be sent to the central contacts listed below.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sampling on admission to ICU (all patients)
Additional sampling to admission samples in
Time frame: 6 months
Primary outcome when functional outcome cannot be assessed.
Time frame: 3-6 months
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.
Time frame: 3-6 months
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.
Time frame: 3-6 months
Glasgow Outcome Scale Extended 1-8 (GOSE 1-8), GOSE 1 representing the worst outcome and GOSE 8 the best outcome.
Time frame: On ICU admission
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.
Time frame: 3 and 12 months
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.
Time frame: 3, 12 and 36 months
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).
Time frame: 3, 12 and 36 months
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.
Time frame: 3, 12 and 36 months
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.
Time frame: 3, 12 and 36 months
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.
Skane University Hospital
Other
Acronym: SWECRIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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