Clinical trial NCT04071067: Anemia of Inflammation and Deficiency Anemia
Official title: Anemia of Inflammation and Deficiency Anemia in Critically Ill Patients; Biological Markers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia, Iron Deficiency
Anemia of Chronic Disease
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to ICU during the study period which do not meet any exclusion criteria

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.


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

Primary outcomes:
measure: Change in hemoglobin levels during ICU stay
timeFrame: 21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;
measure: Number of transfusions during ICU stay
timeFrame: Up to 3 months of hospital stay
Secondary outcomes:
measure: Days spent on ICU
timeFrame: Up to 3 months of hospital stay
measure: Days spent in hospital
timeFrame: Up to 3 months
measure: Change in hemoglobin level during hospital stay
timeFrame: Up to 3 months: week 3=point 1; week 6=point 2; week 9=point 3; week 12=point4
measure: Number of hours of mechanical ventilation during hospital stay
timeFrame: Up to 3 months
Other outcomes:
measure: Change in hepcidin levels
timeFrame: Days 0, 3, 7, 14, 21
Locations:
city: Cluj Napoca
country: Romania
facility: Emergency Clinical County Hospital Cluj Napoca
state: Cluj
city: Cluj Napoca
country: Romania
facility: Municipal Clinical Hospital Cluj
state: Cluj
Study officials:
affiliation: 2nd Anesthesia Department of University of Medicine and Pharmacy Cluj Napoca
name: Constantin Bodolea, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.