NCT02854943

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,623

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
16.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

18.6 years

First QC Date

August 1, 2016

Last Update Submit

December 5, 2022

Conditions

Keywords

FerritinHemophagocytic lymphohistiocytosis (HLH)Critically ill patientsintensive care unit (ICU)OutcomeDiagnosis

Outcome Measures

Primary Outcomes (2)

  • Mortality

    A retrospective analysis of patients with available charts to determine the outcome whether patients survived the ICU or died.

    Participants will be followed up for the duration of hospital stay, an expected average of two months

  • Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH)

    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)

    The participants will be followed up for the duration of hospital stay, an expected average of two months

Secondary Outcomes (3)

  • Diagnoses

    Participants will be followed up for the duration of hospital stay, an expected average of two months

  • Intensive care unit 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

    Participants will be followed up for the duration of intensive care unit stay, an expected average of one week

Study Arms (1)

Critically ill patients

Male and female critically ill patients admitted to the Charité - University Medicine Berlin during 2000 and 2018.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male and female critically ill patients admitted to the Charité - Universitätsmedizin Berlin during 2000 and 2018

You may qualify if:

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

You may not qualify if:

  • age below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 16937360BACKGROUND
  • 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.

    PMID: 24782338BACKGROUND
  • 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.

MeSH Terms

Conditions

Lymphohistiocytosis, HemophagocyticMacrophage Activation SyndromeDisease

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gunnar Lachmann, MD

    Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine

    STUDY DIRECTOR
  • Gunnar Lachmann, MD

    Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Operative Intensive Care Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist in Anesthesiology of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 4, 2016

Study Start

January 1, 2000

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share