Investigation of Ferritin in Critically Ill Patients With Hemophagocytic Lymphohistiocytosis (FERRITS)

December 5, 2022 updated by: Gunnar Lachmann

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

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

Study Overview

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

Observational

Enrollment (Actual)

2623

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-age below 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

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.

Clinical Trials on Hemophagocytic Lymphohistiocytosis (HLH)

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