Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)
- Conditions
- Hemophagocytic Lymphohistiocytosis
- Registration Number
- NCT03510650
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Male or female critically ill patients
- At least 18 years old
- Suspected or diagnosed HLH
- Female patients: Pregnancy
- Female patients: Breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of HLH in intensive care units based on HLH-2004 criteria Up to 180 days HLH patients are followed up until the end of hospital stay or death.
- Secondary Outcome Measures
Name Time Method Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads Up to 180 days 1 blood sample collection at time of diagnosed HLH
Perforin and CD107a Up to 180 days 1 blood sample collection at time of diagnosed HLH
Human immunodeficiency virus antibodies and -antigen Up to 180 days 1 blood sample collection at time of diagnosed HLH
Liver transaminase (ASAT) Up to 180 days ASAT \[U/l\]
Sodium Up to 180 days Detailed immune status 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.
Mortality Up to 180 days Mortality after 30 and 180 days
Bilirubin Up to 180 days Serum albumin Up to 180 days Cytokine panel 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
Fibrinogen Up to 180 days Liver transaminases (ALAT) Up to 180 days ALAT \[U/l\]
Glycosylated ferritin Up to 180 days 1 blood sample collection at time of diagnosed HLH
Intensive care unit stay Participants will be followed up for the duration of hospital length of stay, an expected average of 4 weeks Hospital stay Participants will be followed up for the duration of hospital length of stay, an expected average of 8 weeks Lactate dehydrogenase Up to 180 days Lactate dehydrogenase is measured in U/l
microRNAs miR-205-5p, miR-194-5p and miR-30c-5p Up to 180 days 1 blood sample collection at time of diagnosed HLH
Triglycerides Up to 180 days Serum protein electrophoresis 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.
Trial Locations
- Locations (1)
Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany