Iron Homoeostasis in Inflammation

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02155114

Collaborator

(none)

472

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Bacterial Infections and Mycoses Anemia, Iron-Deficiency Iron Overload

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.

Study Design

Study Type:

Observational

Actual Enrollment :

472 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Iron Homoeostasis in Inflammation: A Single Center Observational Cross-sectional Study

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Outcome Measures

Primary Outcome Measures

Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation [up to 8 days]

Secondary Outcome Measures

Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution [up to 8 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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