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

NCT03510650 | Completed

• 1 other identifier: HEMICU
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

Hemophagocytic Lymphohistiocytosis (HLH); Hemophagocytic syndrome (HPS); critically ill; Intensive care unit (ICU)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (19)

• 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

• Mortality

  Up to 180 days

• Cytokine panel

  Up to 180 days

• Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads

  Up to 180 days

Other Outcomes (1)

• HLA Typing

  At the beginning of the investigation

Study Arms (1)

Patients

50 patients with sepsis versus 50 patients with HLH \[anticipated\]

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female critically ill patients admitted to any ICU of the Charité - Universitätsmedizin Berlin.

You may qualify if:

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

You may not qualify if:

• Female patients: Pregnancy
• Female patients: Breastfeeding

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related Publications (2)

• 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.

  PMID: 26705219 BACKGROUND

• 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.

  PMID: 31666276 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic; Critical Illness

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 27, 2018
• Study Start: September 11, 2018
• Primary Completion: June 26, 2022
• Study Completion: December 26, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)