Clinical trial NCT02155114: Iron Homoeostasis in Inflammation
Official title: Iron Homoeostasis in Inflammation: A Single Center Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Bacterial Infections and Mycoses
Anemia, Iron-Deficiency
Iron Overload
Keywords: Hepcidins
Homeostasis
Iron/administration & dosage
Biological Markers/blood
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 472
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive internal medicine inpatients with laboratory signs of inflammation

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.

Detailed description: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation
timeFrame: up to 8 days
Secondary outcomes:
measure: Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution
timeFrame: up to 8 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Basel University Hospital
Study officials:
affiliation: Division of Internal Medicine, University Hospital Basel, Switzerland
name: Balthasar L. Hug, MD, MBA, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Drakesmith H, Prentice AM. Hepcidin and the iron-infection axis. Science. 2012 Nov 9;338(6108):768-72. doi: 10.1126/science.1224577.
citation: 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.