Critical IllnessSWECRITNCT04974775
Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls
An observational study of Critical Illness and Cardiac Arrest, run by Skane University Hospital at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Cardiac Arrest, Sepsis
- What is being tested?
- Blood collection and Blood collection, serial sampling
- How many people
- 8,500 participants
- Where
- 4 sitesSweden
- Study dates
- Jun 2014to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Critically ill patients admitted to the ICU
- 18 years or older
- covid19-verified (covid19-cohort)
Who cannot join
- The patient or next of kin decline participation
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Helsingborg Hospital
Helsingborg
Kristianstad Central Hospital
Kristianstad
Skane University Hospital
Lund
Skane University Hospital
Malmö
About this study
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.
Read the 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.
- 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.
- Assessment of neurological prognosis and outcomes will be a common denominator in several studies.
- 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.
- Conditions
- Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid19, Trauma
- Being tested
- Blood collection, Blood collection, serial sampling
- Keywords
- Biobank, Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid-19, Trauma, Prognosis, Neurology
- Medical subject headings
- Critical Illness, Heart Arrest, Sepsis, Influenza, Human, COVID-19, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionDiagnostic test
Sampling on admission to ICU (all patients)
Blood collection, serial samplingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill | Critically ill patients and patients in need of post-operative intensive care. Receives: Diagnostic Test: Blood collection | |
| Cardiac Arrest | Cardiac Arrest according to the ICD-10 I469 diagnosis. Receives: Diagnostic Test: Blood collection; Diagnostic Test: Blood collection, serial sampling | |
| Sepsis | Sepsis according to the sepsis-3 criteria. Receives: Diagnostic Test: Blood collection | |
| Covid-19 | Critically ill patients with a positive Covid-19 test. Receives: Diagnostic Test: Blood collection; Diagnostic Test: Blood collection, serial sampling | |
| Influenza | Critically ill patients with a positive influenza test. Receives: Diagnostic Test: Blood collection | |
| Trauma | Critically ill patients after a severe traumatic event. Receives: Diagnostic Test: Blood collection | |
| Healthy controls | Healthy at the time of blood sampling Receives: Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (all)
Primary outcome when functional outcome cannot be assessed.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 3-6 months
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.
Measured: 3-6 months
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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study startJun 2014
- Primary completionDec 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 8,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Lund University
- Responsible party
- Principal investigator, Hans Friberg, Skane University Hospital
- Investigators
- Hans Friberg, MD, PhD, Study chair, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974775
- Sponsor's protocol ID
- SWECRIT
- Acronym
- SWECRIT
- Status last verified
- Nov 2024
- First submitted
- 18 Jun 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32463121Lundberg 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.
PubMed 33148300Thorgeirsdottir 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.
PubMed 33930500Johnsson 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.
PubMed 32731878Didriksson I, Toniste D, Hultgren M, Spangfors M, Gobel Andertun S, Nelderup M, Reepalu A, Frigyesi A, Friberg H, Lilja G. Three-year functional, physical, and mental health outcomes after critical COVID-19: A prospective multicentre cohort study. PLoS One. 2026 Feb 18;21(2):e0341319. doi: 10.1371/journal.pone.0341319. eCollection 2026.
PubMed 41706661Arctaedius I, Wasselius J, Lang M, Drake M, Johnsson M, Friberg H, Leithner C, Kenda M, Lybeck A, Moseby-Knappe M. The semi-quantitative cardiac arrest brain ischemia (CABI) score for magnetic resonance imaging predicts functional outcome after cardiac arrest. Crit Care. 2025 Aug 20;29(1):373. doi: 10.1186/s13054-025-05595-1.
PubMed 40836345Didriksson I, Frigyesi A, Spangfors M, Leffler M, Reepalu A, Nilsson AC, Annborn M, Lybeck A, Friberg H, Lilja G. Long-term recovery in critically ill COVID-19 survivors: A prospective cohort study. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14550. doi: 10.1111/aas.14550.
PubMed 39540322Didriksson I, Lengquist M, Spangfors M, Leffler M, Sievert T, Lilja G, Frigyesi A, Friberg H, Schiopu A. Increasing plasma calprotectin (S100A8/A9) is associated with 12-month mortality and unfavourable functional outcome in critically ill COVID-19 patients. J Intensive Care. 2024 Jul 9;12(1):26. doi: 10.1186/s40560-024-00740-4.
PubMed 38982551Arctaedius I, Levin H, Larsson M, Friberg H, Cronberg T, Nielsen N, Moseby-Knappe M, Lybeck A. 2021 European Resuscitation Council/European Society of Intensive Care Medicine Algorithm for Prognostication of Poor Neurological Outcome After Cardiac Arrest-Can Entry Criteria Be Broadened? Crit Care Med. 2024 Apr 1;52(4):531-541. doi: 10.1097/CCM.0000000000006113. Epub 2023 Dec 7.
PubMed 38059722
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT04974775
- Acronym / sponsor ID
- SWECRIT / SWECRIT
- Conditions
- Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid19, Trauma
- Keywords
- Biobank, Critical Illness, Cardiac Arrest, Sepsis, Influenza, Covid-19, Trauma, Prognosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,500 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Region Skane, Lund University
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Assessment of neurological prognosis and outcomes will be a common denominator in several studies.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Critically Ill | – | Diagnostic Test: Blood collectionCritically ill patients and patients in need of post-operative intensive care. |
| Cardiac Arrest | – | Diagnostic Test: Blood collection, Diagnostic Test: Blood collection, serial samplingCardiac Arrest according to the ICD-10 I469 diagnosis. |
| Sepsis | – | Diagnostic Test: Blood collectionSepsis according to the sepsis-3 criteria. |
| Covid-19 | – | Diagnostic Test: Blood collection, Diagnostic Test: Blood collection, serial samplingCritically ill patients with a positive Covid-19 test. |
| Influenza | – | Diagnostic Test: Blood collectionCritically ill patients with a positive influenza test. |
| Trauma | – | Diagnostic Test: Blood collectionCritically ill patients after a severe traumatic event. |
| Healthy controls | – | Diagnostic Test: Blood collectionHealthy at the time of blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Critically ill patients admitted to the ICU
- 18 years or older
- covid19-verified (covid19-cohort)
Key exclusion criteria (1 listed)
- The patient or next of kin decline participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionSampling on admission to ICU (all patients) | Diagnostic test | Cardiac Arrest, Covid-19, Critically Ill, Healthy controls, Influenza, Sepsis, Trauma |
| Blood collection, serial samplingAdditional sampling to admission samples in 1. the Cardiac Arrest group after 12 and 48 hours 2. the Covid-19 group on day 2 and 7 while in the ICU 3. the Covid-19 group after 3 and 12 months. | Diagnostic test | Cardiac Arrest, Covid-19 |
Primary outcome
Mortality (all)
Time frame: 6 months
Primary outcome when functional outcome cannot be assessed.
3 secondary outcomes
Proportion of patients with good neurological outcome 1 (all)
Time frame: 3-6 months
Proportion of patients with good neurological outcome 2 (all)
Time frame: 3-6 months
Neurological outcome 3 (covid19)
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 32463121Lengquist 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.
- Background: PubMed 33148300Lundberg 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.
- Background: PubMed 33930500Thorgeirsdottir 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.
- Background: PubMed 32731878Johnsson 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.
- Derived from this study: PubMed 41706661Didriksson I, Toniste D, Hultgren M, Spangfors M, Gobel Andertun S, Nelderup M, Reepalu A, Frigyesi A, Friberg H, Lilja G. Three-year functional, physical, and mental health outcomes after critical COVID-19: A prospective multicentre cohort study. PLoS One. 2026 Feb 18;21(2):e0341319. doi: 10.1371/journal.pone.0341319. eCollection 2026.
- Derived from this study: PubMed 40836345Arctaedius I, Wasselius J, Lang M, Drake M, Johnsson M, Friberg H, Leithner C, Kenda M, Lybeck A, Moseby-Knappe M. The semi-quantitative cardiac arrest brain ischemia (CABI) score for magnetic resonance imaging predicts functional outcome after cardiac arrest. Crit Care. 2025 Aug 20;29(1):373. doi: 10.1186/s13054-025-05595-1.
- Derived from this study: PubMed 39540322Didriksson I, Frigyesi A, Spangfors M, Leffler M, Reepalu A, Nilsson AC, Annborn M, Lybeck A, Friberg H, Lilja G. Long-term recovery in critically ill COVID-19 survivors: A prospective cohort study. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14550. doi: 10.1111/aas.14550.
- Derived from this study: PubMed 38982551Didriksson I, Lengquist M, Spangfors M, Leffler M, Sievert T, Lilja G, Frigyesi A, Friberg H, Schiopu A. Increasing plasma calprotectin (S100A8/A9) is associated with 12-month mortality and unfavourable functional outcome in critically ill COVID-19 patients. J Intensive Care. 2024 Jul 9;12(1):26. doi: 10.1186/s40560-024-00740-4.
- Derived from this study: PubMed 38059722Arctaedius I, Levin H, Larsson M, Friberg H, Cronberg T, Nielsen N, Moseby-Knappe M, Lybeck A. 2021 European Resuscitation Council/European Society of Intensive Care Medicine Algorithm for Prognostication of Poor Neurological Outcome After Cardiac Arrest-Can Entry Criteria Be Broadened? Crit Care Med. 2024 Apr 1;52(4):531-541. doi: 10.1097/CCM.0000000000006113. Epub 2023 Dec 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Friberg, MD, PhD study chair
Skane University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Cardiac Arrest, run by Skane University Hospital at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (all) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974775, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.