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Iron Homoeostasis in Inflammation

NCT ID: NCT02155114

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Brief Summary

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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.

Detailed Description

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* Background: Iron deficiency is frequently encountered in the elderly, after bleeding and in the context of neoplasia. Our 2013 pilot study showed that iron deficiency is a common problem in medical inpatients (13.7%) and that about 55% of these also showed signs of inflammation. The relevance of iron storage levels on clinical outcome in the presence of inflammation is conflicting. On the one hand, lack of iron prevents many viruses and bacteria, as well as other microorganisms, to reproduce and on the other hand the abundance of available iron stimulates hematopoiesis and reduces symptoms of iron deficiency.
* Methodology: We plan to enroll 1000-1500 patients with laboratory signs of inflammation during a period of six months and to analyze iron specific laboratory parameters twice during hospital stay. Additional laboratory analyses are planned for a smaller sample to portray the processes in iron homeostasis during inflammation.
* Significance: Contradicting evidence of forty and more years of scientific research backs current therapeutic practices in patients with inflammatory disease and iron deficiency. This study records prevalence of different iron storage states, mortality, morbidity and therapies in inflammatory states combined with iron deficiency and could very well be able to recommend a therapeutic regimen as well as limits for typically used laboratory parameters.

Conditions

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Inflammation Bacterial Infections and Mycoses Anemia, Iron-Deficiency Iron Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Balthasar L. Hug, MD, MBA, MPH

Role: PRINCIPAL_INVESTIGATOR

Division of Internal Medicine, University Hospital Basel, Switzerland

Locations

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Basel University Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 24018778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23573815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22160085 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23139325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11160594 (View on PubMed)

Other Identifiers

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EKNZ 2014-053

Identifier Type: OTHER

Identifier Source: secondary_id

EKNZ 2014-053

Identifier Type: -

Identifier Source: org_study_id