Anemia of Inflammation and Deficiency Anemia

Anemia, Iron Deficiency Clinical Trial

— AIDA  

Official title:

Anemia of Inflammation and Deficiency Anemia in Critically Ill Patients; Biological Markers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04071067
• Other study ID #: 89/8.04.2019
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2019
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Robert Szabo, Resident MD
• Phone: 0040755628255
• Email: robsz11[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Of the 783 patients included in the study, 551 (73.37%) had anemia on admission. Frequently anemia is present on discharge from ICU or hospital and may persist for an average of 11 weeks. Some studies have reported the presence of anemia as far as 6 months after discharge. It is widely accepted that anemia has a negative impact on rehabilitation and quality of life, but the treatment can not be exclusively based on blood products due to the risks associated with transfusion. Alternative treatments such as injectable iron or erythropoietin should be considered.

The Transfusion Management Initiative Group recently issued recommendations on perioperative anemia. Similar recommendations for ICU have not yet been developed in Romania. The current study has two main purposes. The first to adopt the perioperative anemia diagnostic algorithm and adapt it to anemic patients on ICU; the second to identify patients with mixed anemia (inflammatory and iron deficient anemia) who can benefit from treatment with iron.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients admitted to ICU

ICU stay >48hours

Exclusion Criteria:

• Refusal to participate in the study

• Allergy to iron products

• Anemia requiring massive transfusion in the last 7 days

• Treatment of iron products in the last 7 days

• Chronic renal failure with GFR <30mL / min or on dialysis

• Metabolism of iron

• Pregnant or lactation patients

• Rheumatic diseases

• Inflammatory bowel diseases

• Hematological pathologies

• Impossibility of performing laboratory tests within 72 hours of admission

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Disease
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Chronic Disease
• Inflammation

Locations

Country	Name	City	State
Romania	Emergency Clinical County Hospital Cluj Napoca	Cluj Napoca	Cluj
Romania	Municipal Clinical Hospital Cluj	Cluj Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Filipescu D, Banateanu R, Beuran M, Burcos T, Corneci D, Cristian D, Diculescu M, Dobrota A, Droc G, Isacoff D, Gosa D, Grintescu I, Lupu A, Mirea L, Posea C, Stanca O, Stefan M, Tomescu D, Tudor C, Ungureanu D, Mircescu G. Perioperative Patient Blood Management Programme. Multidisciplinary recommendations from the Patient Blood Management Initiative Group. Rom J Anaesth Intensive Care. 2017 Oct;24(2):139-157. doi: 10.21454/rjaic.7518.242.fil. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in hepcidin levels	Hepcidin is a peptide produced by the liver. It acts by binding to ferroportin, the sole exporter of iron. The hepcidin-ferroportin complex is sequestrated in the cytosol of cells followed by its degradation. Ferroportin degradation prevents iron from being exported from the cell.	Days 0, 3, 7, 14, 21
Primary	Change in hemoglobin levels during ICU stay		21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;
Primary	Number of transfusions during ICU stay		Up to 3 months of hospital stay
Secondary	Days spent on ICU		Up to 3 months of hospital stay
Secondary	Days spent in hospital		Up to 3 months
Secondary	Change in hemoglobin level during hospital stay		Up to 3 months: week 3=point 1; week 6=point 2; week 9=point 3; week 12=point4
Secondary	Number of hours of mechanical ventilation during hospital stay		Up to 3 months