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

Sponsor
Skane University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04974775
Collaborator
Region Skane (Other), Lund University (Other)
8,500
4
127
2125
16.7

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jun 1, 2014
Actual Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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 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.

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 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.

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)

Outcome Measures

Primary Outcome Measures

  1. Mortality (all) [6 months]

    Primary outcome when functional outcome cannot be assessed.

Secondary Outcome Measures

  1. Proportion of patients with good neurological outcome 1 (all) [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) [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) [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) [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) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsingborg Hospital Helsingborg Sweden
2 Kristianstad Central Hospital Kristianstad Sweden
3 Skane University Hospital Lund Sweden
4 Skane University Hospital Malmö Sweden

Sponsors and Collaborators

  • Skane University Hospital
  • Region Skane
  • Lund University

Investigators

  • Study Chair: Hans Friberg, MD, PhD, Skane University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hans Friberg, Professor, Consultant, Skane University Hospital
ClinicalTrials.gov Identifier:
NCT04974775
Other Study ID Numbers:
  • SWECRIT
First Posted:
Jul 23, 2021
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hans Friberg, Professor, Consultant, Skane University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022