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Active, Not Recruiting

NCT Number: NCT04974775

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Diagnostic Test

Sampling on admission to ICU (all patients)

Blood collection, serial sampling

Diagnostic 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.

Primary outcomes

  1. Mortality (all)

    Time frame: 6 months

    Primary outcome when functional outcome cannot be assessed.

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Lund University
  • Region Skane

Registry information

Acronym: SWECRIT

Important dates

Study start
2014
Primary completion
2021
Study completion
2026
First posted
Jul 23, 2021
Registry last updated
May 29, 2025

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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