Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Serum STREM and MNDA Mointoring in ICU

14 de diciembre de 2014 actualizado por: Ayman Abd Al-maksoud Yousef, Tanta University

The Predictive Values of Serum STREM and Its Correlation With MNDA Monitoring in Critically Ill Patients.

A total of 120 patients will be included in the study. Sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

A total of 120 patients will be included in the study. Sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

At admission, patient's age, sex, weight and height were Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.

The signs of sepsis were body temperature <36C° or > 38C°, tachycardia (>90 beats/min), ventilatory frequency>20 breath/min or Pco2<32mmHg (unless the patient was mechanically ventilated), a white cell count ≥12×109 litre-1 or < 4x 109 litre-1, or >10% immature neutrophils, in addition to the presence of infection. Severe sepsis is a sepsis associated with evidence of organ dysfunction , hypoperfusion, acute alteration of mental status, elevated plasma lactate, unexplained metabolic acidosis (arterial ph<7.3), hypoxaemia, prolonged prothrombin time or decrease in platelet count >50% or ≤100×109litre1, oliguria and hypotension defined as systolic arterial pressure <90mmHg or a decrease of >40mmHg. Septic shock was defined as hypotension (<90/60mmHg) in addition to sepsis syndrome persisting despite adequate fluid resuscitation and requiring intropic support

Tipo de estudio

De observación

Inscripción (Actual)

120

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

    • Algharbyia
      • Tanta, Algharbyia, Egipto, 35217
        • Tanta University Hospitals

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 a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

120 critically ill patients, sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

Descripción

Inclusion Criteria:

  • The patients staying in ICU for more than 24 hours will be included in the study.

Exclusion Criteria:

  • Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.

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
Sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.
SIRS group
Sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
dynamic changes of serum sTREM-1 and MNDA
Periodo de tiempo: one week
determine the dynamic changes of serum sTREM-1 and the corresponding changes of serum MNDA and their correlation in critically ill sepsis and SIRS patients.
one week

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Survival in critically ill sepsis and SIRS patients
Periodo de tiempo: two weeks
determine the dynamic changes of serum sTREM-1 and the corresponding changes of serum MNDA and their correlation in critically ill sepsis and SIRS patients and survival .
two weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Ayman A Yousef, Assistant professor

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 abril de 2013

Finalización primaria (Actual)

1 de abril de 2014

Finalización del estudio (Actual)

1 de mayo de 2014

Fechas de registro del estudio

Enviado por primera vez

18 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2014

Publicado por primera vez (Estimar)

22 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de diciembre de 2014

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

14 de diciembre de 2014

Última verificación

1 de diciembre de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 1637/02/13

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 Sepsis .

3
Suscribir