Observational Study of Iron Metabolism in Anemia in ICU a... | NCT00338234

Studies
Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients

NCT00338234

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

May 6, 2008Estimated

Enrollment

153Actual

Phase

Not provided

Conditions

Anemia
Intensive Care
Cardiac Surgery

Interventions

Not provided

Countries

France

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

Status Module

Record Verification Date

Apr 2007

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

Jun 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jun 16, 2006

First Submission Date that Met QC Criteria

Jun 16, 2006

First Posted Date

Jun 20, 2006Estimated

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

May 5, 2008

Last Update Posted Date

May 6, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
Société Française d'Anesthésie et de Réanimation	OTHER
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

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

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

Detailed Description

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation. The latter is known to interfere with iron metabolism, inducing iron storage instead of using it for hemoglobin synthesis. The discover of a new regulatory hormone of iron metabolism, hepcidin, may help us to better understand the link between inflammation and iron functional deficit. The aim of our study is to observe the variation of usual iron metabolism biological markers and of hepcidin, in order to define the better marker of iron loss in these clinical situations.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac surgery		Successive cardiac surgery patients
Surgical ICU		Successive patients admitted to the surgical ICU for more than 7 days, and experiencing anemia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional iron deficiency		during the study

Secondary Outcomes

Measure	Description	Time Frame
fatigue assessed by the MFI20 score for cardiac surgery patients		at one day,at seven days and at 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anemia (haemoglobin < 10 g/dL)
Hospitalization in ICU for an expected duration of 7 days or more
Or, day one post cardiac surgery

Exclusion Criteria:

Chronic anemia (Hb < 9 g/dL for more than one month before hospitalization)
Iron metabolism disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

For the surgery :population 20 yers to 88 years old
For the reanimation : population to the 41 years to 85 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sigismond lasocki, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator
Carole Beaumont, PhD	Institut National de la Santé Et de la Recherche Médicale, France	Study Chair
Isabelle Boutron, MD	Institut National de la Santé Et de la Recherche Médicale, France	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
APHP, hopital Bichat		Paris		75018	France

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided