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Efficacy of Intravenous Iron Administration in Hemodialysis Patients

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EstadoTerminado
Patrocinadores
Kumamoto University

Palabras clave

Abstracto

The purpose of this study is to determine whether the frequency of intravenous iron administration has an effect on anemia correction and oxidative stress formation in hemodialysis patients.

Descripción

In patients who are on chronic hemodialysis (HD), anemia is a major complication and is associated with poor clinical outcomes. Consequently, management of anemia by recombinant erythropoietin is reported consistently to improve outcome measures in HD patients. Because iron is essential for hemoglobin formation, as is erythropoietin, most patients routinely receive iron intravenously (IVIR) for anemia correction. Although IVIR has been shown to improve both survival and quality of life of HD patients, it has been suggested that IVIR may enhance the generation of hydroxyl radicals in the body through the inflammation process and the Fenton reaction. Previously we demonstrated that that serum albumin is highly oxidized in HD patients and that IVIR on these patients significantly increased the oxidation status of albumin.

In 2004, the committee on the guidelines of the Japanese Society for Dialysis Therapy (JSDT) published the original Japanese "Guidelines for Renal Anemia in Chronic Hemodialysis Patients". In the JSDT guidelines 2004, the committee recommended two IVIR schedules for iron deficient patients; 1) administer 40 mg of IV iron at the end of dialysis session 3 times a week for 4 weeks (total 520 mg of iron), 2) administer 40 mg of IV iron at the end of dialysis session once a week for 3 months (total 520 mg of iron). Both administration schedules are effective for the correction of iron deficiency and consequently for the amelioration of anemia. However, the effect of IVIR frequency (three times a week vs. once a week) on the oxidative stress formation has not been investigated before.

Comparison: the two IVIR schedules recommended by the JSDT guideline 2004 will be compared by measuring both hemoglobin and oxidized albumin in chronic HD patients.

fechas

Verificado por última vez: 04/30/2008
Primero enviado: 02/27/2006
Inscripción estimada enviada: 02/27/2006
Publicado por primera vez: 03/01/2006
Última actualización enviada: 05/07/2008
Última actualización publicada: 05/11/2008
Fecha de inicio real del estudio: 05/31/2005
Fecha estimada de finalización primaria: 04/30/2006
Fecha estimada de finalización del estudio: 02/28/2007

Condición o enfermedad

Chronic Renal Failure
Hemodialysis
Renal Anemia
Iron Deficiency Anemia

Intervención / tratamiento

Drug: chondroitin sulfate-iron colloid

Fase

Fase 4

Criterio de elegibilidad

Edades elegibles para estudiar 18 Years A 18 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

Inclusion Criteria:

- Clinical diagnosis of chronic renal failure

- Clinical diagnosis of iron deficiency anemia

- Must be on regular hemodialysis

Exclusion Criteria:

- Allergic to intravenous iron administration

Salir

Medidas de resultado primarias

1. hemoglobin levels at 24 weeks [undefined]

2. oxidized albumin levels at 24 weeks [undefined]

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