The Prognostic and Diagnostic Value of Ferritin in Critically Ill Patients With Special Focus on Underlying Hemophagocytic Lymphohistiocytosis

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02854943
Collaborator
(none)
2,623
223

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2623 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Prognostic and Diagnostic Value of Ferritin in Critically Ill Patients With Special Focus on Underlying Hemophagocytic Lymphohistiocytosis
    Actual Study Start Date :
    Jan 1, 2000
    Actual Primary Completion Date :
    Aug 1, 2018
    Actual Study Completion Date :
    Aug 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Critically ill patients

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

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [Participants will be followed up for the duration of hospital stay, an expected average of two months]

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

    2. Probability of having undiagnosed Hemophagocytic lymphohistiocytosis (HLH) [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)

    Secondary Outcome Measures

    1. Diagnoses [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

    2. Intensive care unit stay [Participants will be followed up for the duration of intensive care unit stay, an expected average of one week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • male and female patients

    • at least one measurement of plasma ferritin

    Exclusion Criteria:

    -age below 18 years

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Claudia Spies, Head of Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02854943
    Other Study ID Numbers:
    • HLH
    First Posted:
    Aug 4, 2016
    Last Update Posted:
    Aug 21, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 21, 2019