Anemia of Inflammation and Deficiency Anemia

NCT04071067 | Unknown

• 1 other identifier: 89/8.04.2019
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Anemia, Iron Deficiency; Anemia of Chronic Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 Outcomes (1)

• Change in hepcidin levels

  Days 0, 3, 7, 14, 21

Study Arms (2)

Emergency Clinical County Hospital Group

Municipal Clinical Hospital Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients admitted to ICU
• ICU stay \>48hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (2)

Emergency Clinical County Hospital Cluj Napoca

Cluj-Napoca, Cluj, Romania

Location

Municipal Clinical Hospital Cluj

Cluj-Napoca, Cluj, Romania

Location

Related 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.

  PMID: 29090267 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Constantin Bodolea, Md PhD

  2nd Anesthesia Department of University of Medicine and Pharmacy Cluj Napoca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Szabo, Resident MD

CONTACT

0040755628255; robsz11@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of 2nd Anesthesia Department

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: August 28, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: July 1, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

RO (2)