Clinical trial NCT02854943: Investigation of Ferritin in Critically Ill Patients With Hemophagocytic Lymphohistiocytosis
Official title: The Prognostic and Diagnostic Value of Ferritin in Critically Ill Patients With Special Focus on Underlying Hemophagocytic Lymphohistiocytosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophagocytic Lymphohistiocytosis (HLH)
Macrophage Activation Syndrome (MAS)
Hemophagocytic Syndromes
Keywords: Ferritin
Hemophagocytic lymphohistiocytosis (HLH)
Critically ill patients
intensive care unit (ICU)
Outcome
Diagnosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 2623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female critically ill patients admitted to the Charité - Universitätsmedizin Berlin during 2000 and 2018

Brief summary: Retrospective analysis of ferritin, outcome and HLH-criteria in critically ill patients.

Detailed description: The study is a retrospective register study of critically ill patients from Charité - Universitätsmedizin Berlin during 2000 and 2016 that had at least one measurement of plasma ferritin. Outcome, underlying diagnoses and HLH-2004 criteria (Henter JI et al. 2007) will be analyzed and the HScore of these patients will be calculated (Fardet L et al. 2014). All recorded data of the specific admission term in ICU will be used for the analysis. No follow-up of the patients after discharge will be performed in this study. The study does not involve any randomization or any drug testing.

Update 2019: We expanded our database for the years until 2018 and also for the surgical and medical ICUs of the Charité - Universitätsmedizin Berlin (from 256 to 2623 patients).

Update 2022: A systematic literature search will be performed to find suitable validation cohorts for multicenter validation of optimized HLH diagnostic criteria, which are calculated based on our data (new secondary endpoint).

Eligibility criteria: Inclusion Criteria:

* male and female patients
* at least one measurement of plasma ferritin

Exclusion Criteria:

-age below 18 years

Primary outcomes:
measure: Mortality
timeFrame: Participants will be followed up for the duration of hospital stay, an expected average of two months
measure: Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)
timeFrame: The participants will be followed up for the duration of hospital stay, an expected average of two months
Secondary outcomes:
measure: Diagnoses
timeFrame: Participants will be followed up for the duration of hospital stay, an expected average of two months
measure: Intensive care unit stay
timeFrame: Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
measure: Improving HLH diagnostic criteria including multicenter validation
timeFrame: Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
Other outcomes:
Locations:
Study officials:
affiliation: Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine
name: Gunnar Lachmann, MD
role: STUDY_DIRECTOR
affiliation: Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine
name: Gunnar Lachmann, MD
role: STUDY_CHAIR
References:
citation: Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039.
citation: Fardet L, Galicier L, Lambotte O, Marzac C, Aumont C, Chahwan D, Coppo P, Hejblum G. Development and validation of the HScore, a score for the diagnosis of reactive hemophagocytic syndrome. Arthritis Rheumatol. 2014 Sep;66(9):2613-20. doi: 10.1002/art.38690.
citation: Knaak C, Schuster FS, Nyvlt P, Heeren P, Spies C, Schenk T, La Rosee P, Janka G, Brunkhorst FM, Lachmann G. Influence of transfusions, hemodialysis and extracorporeal life support on hyperferritinemia in critically ill patients. PLoS One. 2021 Jul 12;16(7):e0254345. doi: 10.1371/journal.pone.0254345. eCollection 2021.
citation: Knaak C, Nyvlt P, Schuster FS, Spies C, Heeren P, Schenk T, Balzer F, La Rosee P, Janka G, Brunkhorst FM, Keh D, Lachmann G. Hemophagocytic lymphohistiocytosis in critically ill patients: diagnostic reliability of HLH-2004 criteria and HScore. Crit Care. 2020 May 24;24(1):244. doi: 10.1186/s13054-020-02941-3.
citation: Knaak C, Schuster FS, Spies C, Vorderwulbecke G, Nyvlt P, Schenk T, Balzer F, La Rosee P, Janka G, Brunkhorst FM, Keh D, Lachmann G. Hemophagocytic Lymphohistiocytosis in Critically Ill Patients. Shock. 2020 Jun;53(6):701-709. doi: 10.1097/SHK.0000000000001454.
citation: Lachmann G, Spies C, Schenk T, Brunkhorst FM, Balzer F, La Rosee P. Hemophagocytic Lymphohistiocytosis: Potentially Underdiagnosed in Intensive Care Units. Shock. 2018 Aug;50(2):149-155. doi: 10.1097/SHK.0000000000001048.