- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02854943
Investigation of Ferritin in Critically Ill Patients With Hemophagocytic Lymphohistiocytosis (FERRITS)
The Prognostic and Diagnostic Value of Ferritin in Critically Ill Patients With Special Focus on Underlying Hemophagocytic Lymphohistiocytosis
Study Overview
Status
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).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- male and female patients
- at least one measurement of plasma ferritin
Exclusion Criteria:
-age below 18 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Critically ill patients
Male and female critically ill patients admitted to the Charité - University Medicine Berlin during 2000 and 2018.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Participants will be followed up for the duration of hospital stay, an expected average of two months
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A retrospective analysis of patients with available charts to determine the outcome whether patients survived the ICU or died.
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Participants will be followed up for the duration of hospital stay, an expected average of two months
|
Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)
Time Frame: The participants will be followed up for the duration of hospital stay, an expected average of two months
|
Retrospective analysis of available charts, underlying diagnoses, findings and blood values: HLH-2004 criteria (Henter JI et al. 2007) and HScore (Fardet L et al. 2014)
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The participants will be followed up for the duration of hospital stay, an expected average of two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnoses
Time Frame: Participants will be followed up for the duration of hospital stay, an expected average of two months
|
Retrospective analysis of available charts and underlying diagnoses
|
Participants will be followed up for the duration of hospital stay, an expected average of two months
|
Intensive care unit stay
Time Frame: Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
|
Retrospective analysis of available charts and duration of ICU stay
|
Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
|
Improving HLH diagnostic criteria including multicenter validation
Time Frame: Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
|
Sensitivity and specificity of HLH diagnostic criteria should be improved by calculating different cutoffs of HLH-2004 criteria.
Combinations with highest sensitivity and specificity will be validated in published cohorts of HLH testing for sensitivity and specificity.
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Participants will be followed up for the duration of intensive care unit stay, an expected average of one week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gunnar Lachmann, MD, Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine
- Study Chair: Gunnar Lachmann, MD, Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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