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

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ClinicalTrials.gov Identifier: NCT04974775
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : July 23, 2021
Sponsor:
Collaborators:
Region Skane
Lund University
Information provided by (Responsible Party):
Hans Friberg, Skane University Hospital

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.

Condition or disease Intervention/treatment
Critical Illness Cardiac Arrest Sepsis Influenza Covid19 Trauma Diagnostic Test: Blood collection Diagnostic Test: Blood collection, serial sampling

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.

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Study Type : Observational
Estimated Enrollment : 8500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Swecrit Biobank - Blood Samples From Critically Ill Patients and Healthy Controls
Actual Study Start Date : June 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2024

Group/Cohort Intervention/treatment
Critically Ill
Critically ill patients and patients in need of post-operative intensive care.
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)

Cardiac Arrest
Cardiac Arrest according to the ICD-10 I469 diagnosis.
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)

Diagnostic Test: Blood collection, serial sampling

Additional 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.

Sepsis
Sepsis according to the sepsis-3 criteria.
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)

Covid-19
Critically ill patients with a positive Covid-19 test.
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)

Diagnostic Test: Blood collection, serial sampling

Additional 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.

Influenza
Critically ill patients with a positive influenza test.
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)

Trauma
Critically ill patients after a severe traumatic event.
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)

Healthy controls
Healthy at the time of blood sampling
Diagnostic Test: Blood collection
Sampling on admission to ICU (all patients)




Primary Outcome Measures :
  1. Mortality (all) [ Time Frame: 6 months ]
    Primary outcome when functional outcome cannot be assessed.


Secondary Outcome Measures :
  1. Proportion of patients with good neurological outcome 1 (all) [ 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.

  2. Proportion of patients with good neurological outcome 2 (all) [ 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.

  3. Neurological outcome 3 (covid19) [ 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.


Other Outcome Measures:
  1. Severity of the Acute Respiratory Distress Syndrome (ARDS) (covid19) [ 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.

  2. Proportion of patients with pathological Pulmonary Function Testing (PFT) [ 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.

  3. Subjective respiratory function (covid19) [ 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).

  4. Physical problems (covid19) [ 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.

  5. Proportion of patients with significant Fatigue (covid19) [ 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.

  6. Hospital Anxiety and Depression Scale (covid19) [ 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.


Biospecimen Retention:   Samples With DNA
Whole blood, plasma, and serum are stored at -80°C in the biobank BD-47 at IDEON, Lund, Sweden.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974775


Contacts
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Contact: Helena Levin, MSc +46 46 176116 helena.levin@med.lu.se
Contact: Hans Friberg, MD, PhD +46 708 144894 hans.a.friberg@gmail.com

Locations
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Sweden
Helsingborg Hospital Recruiting
Helsingborg, Sweden
Contact: Martin Annborn, MD, PhD       martin.annborn@skane.se   
Kristianstad Central Hospital Recruiting
Kristianstad, Sweden
Contact: Martin Spångfors, RN, PhD       martin.spangfors@skane.se   
Skane University Hospital Recruiting
Lund, Sweden
Contact: Anna Lybeck, MD, PhD       anna.lybeck@med.lu.se   
Skane University Hospital Recruiting
Malmö, Sweden
Contact: Hans Friberg, MD, PhD       hans.friberg@skane.se   
Sponsors and Collaborators
Skane University Hospital
Region Skane
Lund University
Investigators
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Study Chair: Hans Friberg, MD, PhD Skane University Hospital
Publications:
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Responsible Party: Hans Friberg, Professor, Consultant, Skane University Hospital
ClinicalTrials.gov Identifier: NCT04974775    
Other Study ID Numbers: SWECRIT
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hans Friberg, Skane University Hospital:
Biobank
Critical Illness
Cardiac Arrest
Sepsis
Influenza
Covid-19
Trauma
Prognosis
Neurology
Additional relevant MeSH terms:
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COVID-19
Heart Arrest
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes
Heart Diseases
Cardiovascular Diseases