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Completed

NCT Number: NCT03510650

Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)

Hemophagocytic lymphohistiocytosis in adults (HLH) is at 68% mortality whereas 78% of all cases remain undiagnosed though therapies are available which clearly reduce mortality. The investigators aim to systematically investigate this life-threatening hyperinflammatory syndrome in intensive care units (ICU) in order to detect biomarkers that are highly sensitive and highly specific for HLH in ICU compared to patients with sepsis.

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Key information

Conditions

Hemophagocytic Lymphohistiocytosis Critical Illness Disease Attributes Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Non-Langerhans-Cell Lymphatic Diseases Lymphohistiocytosis, Hemophagocytic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

The investigators will draw blood samples of 100 patients at the time of diagnosis (each 50 with suspected or diagnosed HLH/sepsis) to determine a cytokine panel (c reactive protein (CRP), procalcitonin (PCT), interleukin (IL) 1β, IL-6, IL-8, IL-10, IL-18, IL-33, tumor necrosis factor (TNF) α, interferon (IFN) ɣ, soluble IL-2 receptor (sIL-2R), the EBV and CMV viral loads, human immunodeficiency virus (HIV) antibodies and -antigen, perforin, fibrinogen, triglycerides, bilirubin, lactate dehydrogenase, liver transaminases, sodium, serum albumin, electrophoresis, glycosylated ferritin, the microRNAs miR-205-5p, miR-194-5p and miR-30c-5p, perforin, CD107a and high immune status (differential blood count, T cells, B cells, NK cells, T helper cells, cytotoxic T cells, CD4 / CD8 ratio, HLA-DR of CD8 +, CD11a of CD8, CD57 of CD8, CD28 of CD8 +, HLA-DR of monocytes, CD56bright and CD69 of NK cells). The results of this study serve the development of new clinical concepts in order to safely diagnose HLH at an early stage, to distinguish from sepsis and to reduce the fatal consequences.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female critically ill patients
  • At least 18 years old
  • Suspected or diagnosed HLH

Exclusion criteria

  • Female patients: Pregnancy
  • Female patients: Breastfeeding

Treatment and study plan

Primary outcomes

  1. Incidence of HLH in intensive care units based on HLH-2004 criteria

    Time frame: Up to 180 days

    HLH patients are followed up until the end of hospital stay or death.

Secondary outcomes

  1. Intensive care unit stay

    Time frame: Participants will be followed up for the duration of hospital length of stay, an expected average of 4 weeks

  2. Hospital stay

    Time frame: Participants will be followed up for the duration of hospital length of stay, an expected average of 8 weeks

  3. Mortality

    Time frame: Up to 180 days

    Mortality after 30 and 180 days

  4. Cytokine panel

    Time frame: Up to 180 days

    1 blood sample of Cytokine panel (CRP, PCT, IL-1β, IL-6, IL-8, IL-10, IL-18, IL-33, TNF-α, IFN-ɣ, sIL-2R, ferritin) collection at time of diagnosed HLH

  5. Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads

    Time frame: Up to 180 days

    1 blood sample collection at time of diagnosed HLH

  6. Glycosylated ferritin

    Time frame: Up to 180 days

    1 blood sample collection at time of diagnosed HLH

  7. microRNAs miR-205-5p, miR-194-5p and miR-30c-5p

    Time frame: Up to 180 days

    1 blood sample collection at time of diagnosed HLH

  8. Perforin and CD107a

    Time frame: Up to 180 days

    1 blood sample collection at time of diagnosed HLH

  9. Human immunodeficiency virus antibodies and -antigen

    Time frame: Up to 180 days

    1 blood sample collection at time of diagnosed HLH

  10. Fibrinogen

    Time frame: Up to 180 days

  11. Triglycerides

    Time frame: Up to 180 days

  12. Bilirubin

    Time frame: Up to 180 days

  13. Lactate dehydrogenase

    Time frame: Up to 180 days

    Lactate dehydrogenase is measured in U/l

  14. Liver transaminase (ASAT)

    Time frame: Up to 180 days

    ASAT [U/l]

  15. Liver transaminases (ALAT)

    Time frame: Up to 180 days

    ALAT [U/l]

  16. Sodium

    Time frame: Up to 180 days

  17. Serum albumin

    Time frame: Up to 180 days

  18. Serum protein electrophoresis

    Time frame: Up to 180 days

    Serum protein Electrophoresis (%) is used to separate and quantify the serum protein components into serum albumin, alpha-1 globulins, alpha-2 globulins, beta 1 and 2 globulins, and gamma Globulins.

  19. Detailed immune status

    Time frame: Up to 180 days

    The immune status is analyzed by differential blood count [/nl], T cells [/nl], B cells [/nl], NK cells [/nl], T helper cells [/nl], cytotoxic T cells [/nl], CD4 / CD8 ratio, HLA-DR of CD8+ [%], CD11a of CD8 [%], CD57 of CD8 [%], CD28 of CD8+ [%], HLA-DR of monocytes [antigen/cell], CD56bright [%] and CD69 [%] of NK cells.

Other outcomes

  1. HLA Typing

    Time frame: At the beginning of the investigation

    HLA testing identifies the major HLA genes a person has inherited and their corresponding antigens that are present on the surface of their cells.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2018
Registry last updated
Jan 4, 2023

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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