Anemia of Inflammation and Deficiency Anemia (AIDA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia, Iron Deficiency; Anemia of Chronic Disease

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Robert Szabo, Resident MD; Phone Number: 0040755628255; Email: robsz11@yahoo.com

Study Locations

• Romania
  • Cluj
    • Cluj Napoca, Cluj, Romania
      • Emergency Clinical County Hospital Cluj Napoca
      • Contact: Robert Szabo, Resident MD; Phone Number: 0040755628255; Email: robsz11@yahoo.com
      • Principal Investigator: Cristina Petrisor, MD PhD
      • Sub-Investigator: Robert Szabo, Resident MD
    • Cluj Napoca, Cluj, Romania
      • Municipal Clinical Hospital Cluj
      • Contact: Robert Szabo, Resident MD; Phone Number: 0040755628255; Email: robsz11@yahoo.com
      • Principal Investigator: Constantin Bodolea, MD PhD
      • Sub-Investigator: Mihaela Ene-Cocis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to ICU during the study period which do not meet any exclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Emergency Clinical County Hospital Group
Municipal Clinical Hospital Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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;
Number of transfusions during ICU stay	Up to 3 months of hospital stay

Secondary Outcome Measures

Outcome Measure	Time Frame
Days spent on ICU	Up to 3 months of hospital stay
Days spent in hospital	Up to 3 months
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
Number of hours of mechanical ventilation during hospital stay	Up to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Principal Investigator: Constantin Bodolea, Md PhD, 2nd Anesthesia Department of University of Medicine and Pharmacy Cluj Napoca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Inflammation; Anemia, Iron-Deficiency; Chronic Disease; Anemia
• Other Study ID Numbers: 89/8.04.2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No