Anemia of Inflammation and Deficiency Anemia

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Patrocinadores

Iuliu Hatieganu University of Medicine and Pharmacy

ENSAYO CLÍNICO: NCT04071067

BioSeek: nct04071067

Palabras clave

Abstracto

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.

fechas

Verificado por última vez:	07/31/2019
Primero enviado:	06/30/2019
Inscripción estimada enviada:	08/25/2019
Publicado por primera vez:	08/27/2019
Última actualización enviada:	08/25/2019
Última actualización publicada:	08/27/2019
Fecha de inicio real del estudio:	12/31/2019
Fecha estimada de finalización primaria:	12/30/2020
Fecha estimada de finalización del estudio:	06/30/2021

Condición o enfermedad

Anemia, Iron Deficiency

Anemia of Chronic Disease

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
Emergency Clinical County Hospital Group
Municipal Clinical Hospital Group

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Método de muestreo	Non-Probability Sample
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

1. 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;]

2. Number of transfusions during ICU stay [Up to 3 months of hospital stay]

Medidas de resultado secundarias

1. Days spent on ICU [Up to 3 months of hospital stay]

2. Days spent in hospital [Up to 3 months]

3. 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]

4. Number of hours of mechanical ventilation during hospital stay [Up to 3 months]

Otras medidas de resultado

1. Change in hepcidin levels [Days 0, 3, 7, 14, 21]

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.