InflammationNCT02155114
Iron Homoeostasis in Inflammation
An observational study of Inflammation and Bacterial Infections and Mycoses, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammation, Bacterial Infections and Mycoses, Anemia, Iron-Deficiency
- How many people
- 472 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive internal medicine inpatients with laboratory signs of inflammation
Who may be able to join
- 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
Who cannot join
- History of terminal renal insufficiency in terms of dialysis or use of erythropoiesis-stimulating agents
- Pregnancy
- History of allogeneic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Homoeostasis in Inflammation: A Single Center Observational Cross-sectional Study
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.
Read the 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.
- Keywords
- Hepcidins, Homeostasis, Iron/administration & dosage, Biological Markers/blood
- Medical subject headings
- Inflammation, Bacterial Infections and Mycoses, Anemia, Iron-Deficiency, Iron Overload
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation
Measured: up to 8 days
Secondary outcomes (1)
Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution
Measured: up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Balthasar L. Hug, MD, MBA, MPH, Principal investigator, Division of Internal Medicine, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155114
- Sponsor's protocol ID
- EKNZ 2014-053
- Other IDs
- EKNZ 2014-053
- Status last verified
- Nov 2014
- First submitted
- 2 Jun 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24018778Thomas 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.
PubMed 23573815Finberg KE. Unraveling mechanisms regulating systemic iron homeostasis. Hematology Am Soc Hematol Educ Program. 2011;2011:532-7. doi: 10.1182/asheducation-2011.1.532.
PubMed 22160085Drakesmith H, Prentice AM. Hepcidin and the iron-infection axis. Science. 2012 Nov 9;338(6108):768-72. doi: 10.1126/science.1224577.
PubMed 23139325Oppenheimer 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.
PubMed 11160594
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Homoeostasis in Inflammation: A Single Center Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02155114
- Acronym / sponsor ID
- EKNZ 2014-053
- Keywords
- Hepcidins, Homeostasis, Iron/administration & dosage, Biological Markers/blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive internal medicine inpatients with laboratory signs of inflammation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of terminal renal insufficiency in terms of dialysis or use of erythropoiesis-stimulating agents
- Pregnancy
- History of allogeneic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation
Time frame: up to 8 days
1 secondary outcome
Correlation between iron states and clinical course of acute inflammation, mode of discharge and iron substitution
Time frame: up to 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 24018778Hug 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.
- Background: PubMed 23573815Thomas 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.
- Background: PubMed 22160085Finberg KE. Unraveling mechanisms regulating systemic iron homeostasis. Hematology Am Soc Hematol Educ Program. 2011;2011:532-7. doi: 10.1182/asheducation-2011.1.532.
- Background: PubMed 23139325Drakesmith H, Prentice AM. Hepcidin and the iron-infection axis. Science. 2012 Nov 9;338(6108):768-72. doi: 10.1126/science.1224577.
- Background: PubMed 11160594Oppenheimer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balthasar L. Hug, MD, MBA, MPH principal investigator
Division of Internal Medicine, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Bacterial Infections and Mycoses, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different iron states (normal iron states, iron deficiency and iron overload) in the context of acute inflammation (time frame: up to 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02155114, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.