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

NCT04974775 | Active Not Recruiting

• 1 other identifier: SWECRIT
• Study Type: observational
• Target: 8,500
• Locations: 1 country
• Sites: 4

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.

Conditions

Critical Illness; Cardiac Arrest; Sepsis; Influenza; Covid19; Trauma

Keywords

Biobank; Critical Illness; Cardiac Arrest; Sepsis; Influenza; Covid-19; Trauma; Prognosis; Neurology

Outcome Measures

Primary Outcomes (1)

• Mortality (all)

  Primary outcome when functional outcome cannot be assessed.

  6 months

Secondary Outcomes (3)

• Proportion of patients with good neurological outcome 1 (all)

  3-6 months

• Proportion of patients with good neurological outcome 2 (all)

  3-6 months

• Neurological outcome 3 (covid19)

  3-6 months

Other Outcomes (6)

• Severity of the Acute Respiratory Distress Syndrome (ARDS) (covid19)

  On ICU admission

• Proportion of patients with pathological Pulmonary Function Testing (PFT)

  3 and 12 months

• Subjective respiratory function (covid19)

  3, 12 and 36 months

Study Arms (7)

Critically Ill

Critically ill patients and patients in need of post-operative intensive care.

Diagnostic Test: Blood collection

Cardiac Arrest

Cardiac Arrest according to the ICD-10 I469 diagnosis.

Diagnostic Test: Blood collection; Diagnostic Test: Blood collection, serial sampling

Sepsis

Sepsis according to the sepsis-3 criteria.

Diagnostic Test: Blood collection

Covid-19

Critically ill patients with a positive Covid-19 test.

Diagnostic Test: Blood collection; Diagnostic Test: Blood collection, serial sampling

Influenza

Critically ill patients with a positive influenza test.

Diagnostic Test: Blood collection

Trauma

Critically ill patients after a severe traumatic event.

Diagnostic Test: Blood collection

Healthy controls

Healthy at the time of blood sampling

Diagnostic Test: Blood collection

Interventions

Blood collection DIAGNOSTIC_TEST

Sampling on admission to ICU (all patients)

Cardiac Arrest; Covid-19; Critically Ill; Healthy controls; Influenza; Sepsis; Trauma

Blood collection, serial sampling DIAGNOSTIC_TEST

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.

Cardiac Arrest; Covid-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Critically ill patients admitted to the ICU
• years or older
• covid19-verified (covid19-cohort)

You may not qualify if:

• The patient or next of kin decline participation

Sponsors & Collaborators

• Skane University Hospital: lead
• Region Skane: collaborator
• Lund University: collaborator

Study Sites (4)

Helsingborg Hospital

Helsingborg, Sweden

Location

Kristianstad Central Hospital

Kristianstad, Sweden

Location

Skane University Hospital

Lund, Sweden

Location

Skane University Hospital

Malmo, Sweden

Location

Related Publications (8)

• 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.

  PMID: 32463121 BACKGROUND

• Lundberg 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.

  PMID: 33148300 BACKGROUND

• Thorgeirsdottir 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.

  PMID: 33930500 BACKGROUND

• Johnsson 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.

  PMID: 32731878 BACKGROUND

• Arctaedius 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.

  PMID: 40836345 DERIVED

• Didriksson 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.

  PMID: 39540322 DERIVED

• Didriksson 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.

  PMID: 38982551 DERIVED

• Arctaedius 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.

  PMID: 38059722 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, and serum are stored at -80°C in the biobank BD-47 at IDEON, Lund, Sweden.

MeSH Terms

Conditions

Critical Illness; Heart Arrest; Sepsis; Influenza, Human; COVID-19; Wounds and Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hans Friberg, MD, PhD

  Skane University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 23, 2021
• Study Start: June 1, 2014
• Primary Completion: December 1, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2025

Record last verified: 2024-11

Locations

SE (4)