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ClinicalTrials.gov ID

NCT04071067

Lead Sponsor

Iuliu Hatieganu University of Medicine and PharmacyOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,000Estimated

Last Update Posted

Aug 28, 2019Actual

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jul 1, 2021Estimated

Official Title

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

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.

• Anemia, Iron Deficiency
• Anemia of Chronic Disease

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Iuliu Hatieganu University of Medicine and PharmacyOTHER

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