NCT02155114

Brief Summary

The purpose of this study is to survey iron storage levels and their prognostic consequences in the context of acute inflammation. The impact of iron substitution in inflammatory states is controversial. We hypothesize that iron substitution may influence outcome in patients in inflammatory states.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
472

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

June 2, 2014

Last Update Submit

November 11, 2014

Conditions

Keywords

HepcidinsHomeostasisIron/administration & dosageBiological Markers/blood

Outcome Measures

Primary Outcomes (1)

  • Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation

    up to 8 days

Secondary Outcomes (1)

  • Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution

    up to 8 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive internal medicine inpatients with laboratory signs of inflammation

You may qualify if:

  • Age: ≥18
  • Hospitalized patient in internal medicine (≥ 24h)
  • Evidence of an inflammatory state, determined as a C reactive protein (CRP) value \>5 mg/l
  • Written informed consent

You may not qualify if:

  • History of terminal renal insufficiency in terms of dialysis or use of erythropoiesis-stimulating agents
  • Pregnancy
  • History of allogeneic stem cell transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basel University Hospital

Basel, 4031, Switzerland

Location

Related Publications (5)

  • Hug BL, Tichelli A, Benkert P, Stirnimann G, Schifferli JA. Diagnosis and treatment of iron deficiency in medical inpatients at a Swiss tertiary university referral hospital: a retrospective observational cohort study of clinical practice. Swiss Med Wkly. 2013 Sep 6;143:w13847. doi: 10.4414/smw.2013.13847. eCollection 2013.

    PMID: 24018778BACKGROUND
  • Thomas DW, Hinchliffe RF, Briggs C, Macdougall IC, Littlewood T, Cavill I; British Committee for Standards in Haematology. Guideline for the laboratory diagnosis of functional iron deficiency. Br J Haematol. 2013 Jun;161(5):639-648. doi: 10.1111/bjh.12311. Epub 2013 Apr 10. No abstract available.

    PMID: 23573815BACKGROUND
  • Finberg KE. Unraveling mechanisms regulating systemic iron homeostasis. Hematology Am Soc Hematol Educ Program. 2011;2011:532-7. doi: 10.1182/asheducation-2011.1.532.

    PMID: 22160085BACKGROUND
  • Drakesmith H, Prentice AM. Hepcidin and the iron-infection axis. Science. 2012 Nov 9;338(6108):768-72. doi: 10.1126/science.1224577.

    PMID: 23139325BACKGROUND
  • Oppenheimer SJ. Iron and its relation to immunity and infectious disease. J Nutr. 2001 Feb;131(2S-2):616S-633S; discussion 633S-635S. doi: 10.1093/jn/131.2.616S.

    PMID: 11160594BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples (serum and heparinized plasma)

MeSH Terms

Conditions

InflammationBacterial Infections and MycosesAnemia, Iron-DeficiencyIron Overload

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Balthasar L. Hug, MD, MBA, MPH

    Division of Internal Medicine, University Hospital Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations