- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02120521
Serum STREM and MNDA Mointoring in ICU
The Predictive Values of Serum STREM and Its Correlation With MNDA Monitoring in Critically Ill Patients.
Descripción general del estudio
Estado
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
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Algharbyia
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Tanta, Algharbyia, Egipto, 35217
- Tanta University Hospitals
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿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
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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.
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one week
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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
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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 .
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two weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayman A Yousef, Assistant professor
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1637/02/13
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Ensayos clínicos sobre Sepsis .
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University of Kansas Medical CenterUniversity of KansasReclutamientoSepticemia | Shock séptico | Síndrome de sepsis | Sepsis, Severa | Sepsis bacteriana | Sepsis BacteriemiaEstados Unidos
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Jip GroenInBiomeReclutamientoColonización Microbiana | Infeccion Neonatal | Sepsis Neonatal, Inicio Temprano | Enfermedad microbiana | Sepsis clínica | Sepsis neonatal con cultivo negativo | Sepsis Neonatal, Inicio Tardío | Sepsis neonatal con cultivo positivoPaíses Bajos
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Indonesia UniversityTerminadoImpacto del tratamiento con heparina no fraccionada en dosis bajas sobre la inflamación en la sepsisSepsis severa con shock séptico | Sepsis severa sin shock sépticoIndonesia
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Ohio State UniversityTerminadoSepsis, Sepsis Severa y Shock SépticoEstados Unidos
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Yale UniversityRetiradoSepsis Neonatal de Inicio Temprano | Sepsis neonatal de inicio tardíoEstados Unidos
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The University of QueenslandRoyal Brisbane and Women's HospitalDesconocido
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsTerminadoSepticemia | Shock séptico | Sepsis severa | Síndrome de sepsisReino Unido
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Karolinska InstitutetÖrebro University, SwedenTerminadoSepticemia | Síndrome de sepsis | Sepsis, SeveraSuecia
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Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital y otros colaboradoresTerminadoSepticemia | Shock séptico | Sepsis severa | Infección | Síndrome de sepsisEstados Unidos
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Inverness Medical InnovationsTerminadoSepticemia | Síndrome de Respuesta Inflamatoria Sistémica | Sepsis severa | Síndrome de sepsisEstados Unidos