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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | 50 patients with sepsis versus 50 patients with HLH [anticipated] |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of HLH in intensive care units based on HLH-2004 criteria | HLH patients are followed up until the end of hospital stay or death. | Up to 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HLA Typing | HLA testing identifies the major HLA genes a person has inherited and their corresponding antigens that are present on the surface of their cells. | At the beginning of the investigation |
Inclusion Criteria:
Exclusion Criteria:
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Male and female critically ill patients admitted to any ICU of the Charité - Universitätsmedizin Berlin.
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26705219 | Background | Barba T, Maucort-Boulch D, Iwaz J, Bohe J, Ninet J, Hot A, Lega JC, Guerin C, Argaud L, Broussolle C, Jamilloux Y, Richard JC, Seve P. Hemophagocytic Lymphohistiocytosis in Intensive Care Unit: A 71-Case Strobe-Compliant Retrospective Study. Medicine (Baltimore). 2015 Dec;94(51):e2318. doi: 10.1097/MD.0000000000002318. | |
| 31666276 |
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| ID | Term |
|---|---|
| D051359 | Lymphohistiocytosis, Hemophagocytic |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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6 ml of blood samples of each patient will be stored in the Biobank of the Berlin Institute of Health, Clinical Research Unit, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, D-13353 Berlin
| Mortality | Mortality after 30 and 180 days | Up to 180 days |
| Cytokine panel | 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 | Up to 180 days |
| Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads | 1 blood sample collection at time of diagnosed HLH | Up to 180 days |
| Glycosylated ferritin | 1 blood sample collection at time of diagnosed HLH | Up to 180 days |
| microRNAs miR-205-5p, miR-194-5p and miR-30c-5p | 1 blood sample collection at time of diagnosed HLH | Up to 180 days |
| Perforin and CD107a | 1 blood sample collection at time of diagnosed HLH | Up to 180 days |
| Human immunodeficiency virus antibodies and -antigen | 1 blood sample collection at time of diagnosed HLH | Up to 180 days |
| Fibrinogen | Up to 180 days |
| Triglycerides | Up to 180 days |
| Bilirubin | Up to 180 days |
| Lactate dehydrogenase | Lactate dehydrogenase is measured in U/l | Up to 180 days |
| Liver transaminase (ASAT) | ASAT [U/l] | Up to 180 days |
| Liver transaminases (ALAT) | ALAT [U/l] | Up to 180 days |
| Sodium | Up to 180 days |
| Serum albumin | Up to 180 days |
| Serum protein electrophoresis | 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. | Up to 180 days |
| Detailed immune status | 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. | Up to 180 days |
| Lachmann G, Knaak C, von Haefen C, Paeschke N, Meisel C, Nyvlt P, Schuster FS, Piper SK, Kruppa J, Vorderwulbecke G, Balzer F, La Rosee P, Schenk T, Unterwalder N, Kolsch U, Lachmann N, Akyuz L, Brunkhorst FM, Volk HD, Keh D, Spies C. Diagnostic biomarkers for adult haemophagocytic lymphohistiocytosis in critically ill patients (HEMICU): a prospective observational study protocol. BMJ Open. 2019 Oct 30;9(10):e032695. doi: 10.1136/bmjopen-2019-032695. |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |