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Impact of Clinical, Demographic and Laboratory Variables on Brain Natriuretic Peptide Levels

3 de agosto de 2011 actualizado por: Rambam Health Care Campus

Brain natriuretic peptide (BNP) is involved in the regulation of blood pressure and fluid volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to the emergency room with dyspnea. Interleukin-6 (IL-6) is a cytokine marker of inflammation that exhibits significant prognostic value in predicting severity and outcome of sepsis. Recently, it was suggested that inflammatory cytokines play an important role in the development of heart failure. Procalcitonin (PCT) is a propeptide of calcitonin which is normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT remain very low, a dramatic increase in serum PCT levels is observed during severe systemic infections. These properties make procalcitonin less useful for the diagnosis of simple infections but a very promising marker of severe infections especially in the critical care setting.

To investigate the co-relation between BNP, IL-6 and procalcitonin in two groups of patients; those presenting with the diagnosis of decompensated heart failure and in patients presenting with the diagnosis of sepsis without cardiovascular or hemodynamic dysfunction.

Descripción general del estudio

Estado

Retirado

Descripción detallada

Brain natriuretic peptide (BNP), forms together with atrial natriuretic peptide (ANP) a peptide family involved in the regulation of blood pressure and fluid volume. It is used for the early diagnosis of heart failure (HF) in patients presenting to the emergency room with dyspnea. Additionally, in patients with chronic HF and acute and chronic coronary syndrome, BNP is a marker of unfavorable prognosis, being associated with increased mortality.

Recently, elevated BNP levels have been measured in patients with septic shock and have been attributed to myocardial dysfunction due to sepsis. Because BNP synthesis is also induced by endotoxin and inflammatory mediators, the mechanisms leading to elevated BNP levels in patients with sepsis remain unclear.

Interleukin-6 (IL-6) is a cytokine marker of inflammation that exhibits significant prognostic value in predicting severity and outcome of sepsis, since it is considered to play a key role in the pathogenesis of sepsis. Accumulating evidence suggests that inflammatory cytokines play an important role in the development of heart failure. In particular, studies using genetically engineered animal models have demonstrated the critical role of the gp130-dependent cardiomyocyte survival pathway in the transition to heart failure. However, the significance of gp130 for patients with CHF has not been fully assessed. Previous clinical studies showed that the plasma level of IL-6 is elevated in patients with advanced CHF and that such high levels are associated with a poor prognosis for CHF patients.

Procalcitonin (PCT) is a propeptide of calcitonin which is normally produced in the C-cells of the thyroid glands. Although physiologic levels of PCT remain very low, a dramatic increase in serum PCT levels is observed during severe systemic infections. It is not infection per se but infection accompanied by severe systemic reactions or poor organ perfusion that increases procalcitonin levels. These properties make procalcitonin less useful for the diagnosis of simple infections but a very promising marker of severe infections especially in the critical care setting.

Few studies have investigated the role of procalcitonin in patients with acute heart failure, although there was a slightly increased level of procalcitonin in patients with severe acute heart failure, the results were not conclusive. These results support the hypothesis that inflammatory process has a role in heart failure.

Tipo de estudio

De observación

Inscripción (Actual)

60

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Haifa, Israel, 31096
        • Internal Medicine "B", Rambam Medical center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The study will be performed at Rambam Medical Center, Israel. Patients admitted to the department of internal medicine will be divided to two groups

Descripción

Inclusion Criteria:

  • 1) Patients with decompensated heart failure (N-60).
  • 2) Patients with sepsis (N-60).

Exclusion Criteria:

  • 1) Patients who are under the age of 18 years
  • 2) pregnant women.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Sepsis Group, Heart failure group

The first group will include 60 patients with the diagnosis of acute decompensated heart failure.

The second group will include 60 patients with the diagnosis of sepsis.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Zaher S Azzam, MD, Head Of Internal Medicine "B"

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2009

Finalización primaria (Actual)

1 de junio de 2010

Finalización del estudio (Actual)

1 de junio de 2010

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

24 de junio de 2011

Publicado por primera vez (Estimar)

27 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de agosto de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

3 de agosto de 2011

Última verificación

1 de agosto de 2011

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 0459-09-RMB

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Insuficiencia cardiaca

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