Anemia of Inflammation and Deficiency Anemia

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

• Registration Number: NCT04071067
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-01
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of transfusions during ICU stay	Up to 3 months of hospital stay
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;

Secondary Outcome Measures

Name	Time	Method
Days spent in hospital	Up to 3 months
Number of hours of mechanical ventilation during hospital stay	Up to 3 months
Days spent on ICU	Up to 3 months of hospital stay
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

Trial Locations

Locations (2)

Municipal Clinical Hospital Cluj; 🇷🇴 Cluj Napoca, Cluj, Romania

Emergency Clinical County Hospital Cluj Napoca; 🇷🇴 Cluj Napoca, Cluj, Romania