Iron Homoeostasis in Inflammation | NCT02155114

Studies
Iron Homoeostasis in Inflammation

NCT02155114

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Nov 13, 2014Estimated

Enrollment

472Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EKNZ 2014-053	Other Identifier	Ethikkommission Nordwest- und Zentralschweiz

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 2014Actual

Completion Date

Not provided

First Submitted Date

Jun 2, 2014

First Submission Date that Met QC Criteria

Jun 3, 2014

First Posted Date

Jun 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2014

Last Update Posted Date

Nov 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

472Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution		up to 8 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive internal medicine inpatients with laboratory signs of inflammation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Balthasar L. Hug, MD, MBA, MPH	Division of Internal Medicine, University Hospital Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Basel University Hospital		Basel		4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24018778	Background	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.
23573815

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections
D000747	Anemia, Hypochromic

ID	Term
D007249	Inflammation
D001423	Bacterial Infections and Mycoses
D018798	Anemia, Iron-Deficiency
D019190	Iron Overload